AtherosclerosisNCT01468974
ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System
A study testing ESPRIT BVS in people with Atherosclerosis and Peripheral Vascular Disease, run by Abbott Medical Devices at 8 sites in 4 countries.
Trial summary
The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atherosclerosis, Peripheral Vascular Disease, Claudication
- What is being tested?
- ESPRIT BVS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Nov 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 and ≤ 80 years of age at the time of signing informed consent.
- Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 1-3).
- For subjects with bilateral lesions, the higher Rutherford-Becker Clinical Category limb will be considered the target extremity to be treated in this trial.
- If both limbs are of the same Rutherford Becker Clinical Category, the target extremity will be selected based on investigator discretion.
- Subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and is able to provide informed consent.
- Subject agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
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- Female subject of childbearing potential must: have had a negative pregnancy test within 14 days before treatment; not be nursing at the time of the study procedure and agree at time of consent to use birth control during participation in this trial.
- Subject has life expectancy > 12 months.
- Subject is able to take clopidogrel or prasugrel (or ticlopidine, if the subject cannot take clopidogrel or prasugrel) and acetylsalicylic acid (aspirin).
- Subject must agree not to participate in any other clinical investigation for a period of 12 months following the index procedure. This includes clinical trials of medications and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.
- Angiographic Inclusion Criteria
- A single de novo native disease segment of the superficial femoral (SFA) or common or external iliac arteries of the target extremity located within the following anatomical parameters:
- Iliac
- Proximal margin of target lesion is ≥ 2.5 cm distal to the aortic bifurcation in common iliac artery
- Distal margin of target lesion is ≥ 1.5 cm proximal to the location of inguinal ligament
- SFA
- Proximal margin of target lesion is ≥ 1 cm distal to the common femoral artery bifurcation
- Distal margin of target lesion is ≤ 25 cm distal to the common femoral artery bifurcation
- Vessel diameter from ≥ 5.5 mm to ≤ 6.5 mm evaluated by on-line quantitative vascular angiography (QVA) after pre-dilatation per core laboratory guidelines
- Target lesion is ≥ 50% DS
- Target lesion length ≤ 50 mm
- Patent inflow artery free from significant lesion (≥ 50% DS and < 100% DS) as confirmed by angiography (treatment of the target lesion acceptable after successful treatment of inflow artery lesion)
- Patent popliteal artery free from significant lesion (≥ 50% DS) with at least one patent distal outflow artery (anterior tibial, posterior tibial, or peroneal) that provides in-line circulation to the lower leg and foot, as confirmed by angiography
Who cannot join
- A platelet count <100,000 cells/mm3 or >700,000 cells/mm3; a white blood cell count (WBC) <3,000 cells/mm3; or hemoglobin < 10.0 g/dL
- Acute or chronic renal dysfunction (creatinine > 2.5 mg/dl or >176μmol/L)
- Severe liver impairment as defined by total bilirubin ≥ 3 mg/dl or two times increase over the normal level of serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT).
- Known allergies to the following: aspirin, clopidogrel, prasugrel or ticlopidine, heparin, contrast agent (that cannot be adequately premedicated), or drugs similar to everolimus (i.e. tacrolimus, sirolimus, zotarolimus) or other macrolides.
- Subject requires planned procedure that would necessitate the discontinuation of clopidogrel, prasugrel or ticlopidine.
- Subject has had or will require treatment with drug eluting stent (DES) or drug coated balloon (DCB) within 6 months pre- or post-index procedure.
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- Subject is unable to walk.
- Subject has undergone any non-iliac percutaneous intervention, e.g. coronary, carotid, < 30 days prior to the planned index procedure.
- Subject has received, or is on the waiting list for, a organ transplant.
- Subject is on chronic hemodialysis.
- Subject has uncontrolled diabetes mellitus (DM) (HbA1c ≥ 7.0%).
- Subject has had a myocardial infarction (MI) within the previous 30 days of the planned index procedure.
- Subject has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the subject's ability to walk.
- Subject has unstable angina defined as rest angina with ECG changes.
- Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment.
- Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.
- Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation or is associated with limited life-expectancy, i.e., less than 12 months.
- Subject is currently participating in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.)
- Subject is unable to understand or unwilling to cooperate with study procedures.
- Subject requires general anesthesia for the procedure.
- Subject has ischemic or neuropathic ulcers on either foot.
- Subject has prior minor or major amputation of either lower extremity.
- Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.
- Angiographic Exclusion Criteria
- Contralateral lesion distal to the location of inguinal ligament that requires treatment within 30 days before or after the procedure. (Contralateral iliac artery lesions may be treated during the procedure if necessary for contralateral approach to the target lesion).
- Target extremity has an angiographically significant (> 50% DS) lesion located distal to the target lesion.
- Acute ischemia of the target extremity
- Target extremity has been previously treated with any of the following: surgical bypass or endarterectomy.
- Target vessel has been previously treated with any of the following: stent, laser, atherectomy, surgical bypass, or endarterectomy.
- Total occlusion (100% DS) of the ipsilateral inflow artery.
- Angiographic evidence of thrombus in target vessel.
- The target lesion requires treatment with a device other than percutaneous transluminal angioplasty (PTA) (e.g. but not limited to, directional atherectomy, excimer laser, rotational atherectomy, brachytherapy, cryoplasty, etc.)
- Target lesion is within or adjacent to an aneurysm.
- Subject has angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion, or from crossing or pre-dilating the target lesion.
- Target lesion has moderate-to-severe calcification with either of the following characteristics:
- Circumferential orientation
- Thickness > 2 mm in either radial or longitudinal direction
- Subject has an abdominal aortic aneurysm > 3 cm or history of aortic revascularization.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Belgium4 sites
Abbott Vascular International BVBA
Brussels, 0886.537.933
Sint-Blasius Hospital
Dendermonde
Oost Limburg Ziekenhuis
Genk
Gent University Hospital
Ghent
Germany2 sites
Herzzentrum Bad Krozingen
Bad Krozingen
Park-Krankenhaus Leipzig
Leipzig
About this study
Official title: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System for the Treatment of Subjects With Symptomatic Claudication From Occlusive Vascular Disease of the Superficial Femoral (SFA) or Common or External Iliac Arteries.
The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
- Conditions
- Atherosclerosis, Peripheral Vascular Disease, Claudication
- Being tested
- ESPRIT BVS
- Medical subject headings
- Atherosclerosis, Peripheral Vascular Diseases, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPRIT BVSDevice
Subjects receiving ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries
| Study group | Role | What they receive |
|---|---|---|
| ESPRIT BVS | Other | Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries. Receives: Device: ESPRIT BVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Success
Study device success is defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.
Measured: On Day 0 (From start of index procedure to end of index procedure)
Technical Success
Technical success is defined on a per lesion basis, the attainment of a final residual stenosis of < 30% at the intended target lesion(s). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as technical success only if the above criteria are met.
Measured: On Day 0 (From start of index procedure to end of index procedure)
Clinical Success
Defined on a per subject basis, as the attainment of a final residual stenosis of < 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications* within 2 days after the index procedure or at hospital discharge, whichever is sooner. (Note that in the ESPRIT I study, only a single target lesion per subject is permitted to be treated).
*Includes the following: Death; Amputation; Scaffold Thrombosis; Target Lesion Revascularization (by any percutaneous or surgical means); Target Vessel Revascularization (by any percutaneous or surgical means).
Measured: > or = 2 days after the index procedure
Secondary outcomes (125)
Number of Participants With Death
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
-Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 1 month
Number of Participants With Death
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
-Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 6 months
Number of Participants With Death
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
-Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 1 year
Number of Participants With Death
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
-Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 2 years
Number of Participants With Death
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)
-Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Measured: 3 years
Number of Participants With Any Amputation of Treated Limb (Minor and Major)
The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.
A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
Measured: 1 month
Number of Participants With Any Amputation of Treated Limb (Minor and Major)
The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.
A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
Measured: 6 months
Number of Participants With Any Amputation of Treated Limb (Minor and Major)
The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.
A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
Measured: 1 year
Number of Participants With Any Amputation of Treated Limb (Minor and Major)
The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.
A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
Measured: 2 years
Number of Participants With Any Amputation of Treated Limb (Minor and Major)
The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.
A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
Measured: 3 years
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity
Amputation:
The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.
A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
Measured: 0 to 30 days
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity
Amputation:
The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.
A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
Measured: 0 to 180 days
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity
Amputation:
The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.
A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
Measured: 0 to 365 days
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity
Amputation:
The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.
A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
Measured: 0 to 730 days
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity
Amputation:
The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.
A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
Measured: 0 to 1095 days
Number of Participants With Scaffold Thrombosis
Scaffold Thrombosis is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs within 30 days post- index procedure.
Measured: 0 to 1 month
Scaffold Occlusion
Number of participants with Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.
Measured: 1 month
Number of Participants With Scaffold Occlusion
Scaffold Thrombosis is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs within 30 days post- index procedure.
Measured: 6 months
Number of Participants With Scaffold Occlusion
Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.
Measured: 1 year
Number of Participants With Scaffold Occlusion
Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.
Measured: 2 years
Number of Participants With Scaffold Occlusion
Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.
Measured: 0 to 3 years
Number of Participants With Target Lesion Revascularization (TLR)
Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Measured: 1 month
Number of Participants With Target Lesion Revascularization (TLR)
Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Measured: 6 months
Number of Participants With Target Lesion Revascularization (TLR)
Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Measured: 1 year
Number of Participants With Target Lesion Revascularization (TLR)
Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Measured: 2 years
Number of Participants With Target Lesion Revascularization (TLR)
Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Measured: 3 years
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)
A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
Measured: 1 month
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)
A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
Measured: 6 months
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)
A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
Measured: 1 year
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)
A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
Measured: 2 years
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)
A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
Measured: 3 years
Number of Participants With Ipsilateral Extremity Revascularization (IER)
Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.
Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.
Measured: 1 month
Number of Participants With Ipsilateral Extremity Revascularization (IER)
Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.
Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.
Measured: 6 months
Number of Participants With Ipsilateral Extremity Revascularization (IER)
Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.
Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.
Measured: 1 year
Number of Participants With Ipsilateral Extremity Revascularization (IER)
Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.
Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.
Measured: 2 years
Number of Participants With Ipsilateral Extremity Revascularization (IER)
Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.
Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.
Measured: 3 years
Number of Participants With Primary Patency
At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.
Measured: 1 month
Number of Participants With Primary Patency
At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.
Measured: 6 months
Number of Participants With Primary Patency
At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.
Measured: 1 year
Number of Participants With Primary Patency
At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.
Measured: 2 years
Number of Participants With Primary Patency
At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.
Measured: 3 years
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Measured: 1 month
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Measured: 6 months
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Measured: 1 year
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Measured: 2 years
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.
Category and Clinical Description:
0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Measured: 3 years
Ankle Brachial Index (ABI) for the Treated Limb
The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.
An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.
Calculation of the Ankle Brachial Index:
(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)
Measured: At 1 month
Ankle Brachial Index (ABI) for the Treated Limb
The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.
An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.
Calculation of the Ankle Brachial Index:
(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)
Measured: At 6 months
Ankle Brachial Index (ABI) for the Treated Limb
The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.
An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.
Calculation of the Ankle Brachial Index:
(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)
Measured: At 1 year
Ankle Brachial Index (ABI) for the Treated Limb
The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.
An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.
Calculation of the Ankle Brachial Index:
(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)
Measured: At 2 years
Ankle Brachial Index (ABI) for the Treated Limb
The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.
An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.
Calculation of the Ankle Brachial Index:
(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)
Measured: At 3 years
Walking Impairment Questionnaire (WIQ) Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication.
The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Measured: At 1 month
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Measured: At 6 months
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Measured: At 1 year
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Measured: At 2 years
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Measured: At 3 years
In-scaffold Peak Systolic Velocity (PSV)
In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound
Measured: 1 month
In-scaffold Peak Systolic Velocity (PSV)
In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound
Measured: 6 months
In-scaffold Peak Systolic Velocity (PSV)
In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound
Measured: 1 year
In-scaffold Peak Systolic Velocity (PSV)
In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound
Measured: 2 years
In-scaffold Peak Systolic Velocity (PSV)
In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound
Measured: 3 years
In-scaffold Peak Systolic Velocity Ratio (PSVR)
In-scaffold Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound
Measured: 1 month
In-scaffold Peak Systolic Velocity Ratio (PSVR)
Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound
Measured: 6 months
In-scaffold Peak Systolic Velocity Ratio (PSVR)
Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound
Measured: 1 year
In-Scaffold Peak Systolic Velocity Ratio (PSVR)
Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound
Measured: 2 years
In-scaffold Peak Systolic Velocity Ratio (PSVR)
Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound
Measured: 3 years
Treated Site Percent Diameter Stenosis (%DS)
Percent diameter stenosis (%DS) value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QA.
- Reference Vessel Diameter (RVD)
- Minimum Luminal Diameter(MLD)
Measured: post-procedure
Treated Site Percent Diameter Stenosis (%DS)
Percent diameter stenosis (%DS) value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QA.
- Reference Vessel Diameter (RVD)
- Minimum Luminal Diameter(MLD)
Measured: 12 months
Treated Site Late Loss
Mean in-lesion Late Loss is calculated as: (MLD post-procedure - MLD follow-up).
The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, treated site or treated segment. Minimum Lumen Vessel Diameter (MLD) is visually estimated during angiography by the Investigator; it is measured during qualitative comparative analysis (QCA) by the Angiographic Core Lab.
Measured: 12 months
Binary Restenosis (≥50% DS)
Binary restenosis is defined as the presence of a hemodynamically significant stenosis ≥ 50% as determined by duplex ultrasound or quantitative angiography (QA).
Scaffold Stenosis ≥ 50% by Duplex Ultrasound Only
In-scaffold %DS ≥ 50% by Arteriogram Only
Measured: 1 year
Quality of Life Measures: Physical Functioning (PF) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 month
Quality of Life Measures: Physical Functioning (PF) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 6 months
Quality of Life Measures: Physical Functioning (PF) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 year
Quality of Life Measures: Physical Functioning (PF) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 2 years
Quality of Life Measures: Physical Functioning (PF) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 3 years
Quality of Life Measures: Role Physical (RP) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 month
Quality of Life Measures: Role Physical (RP) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 6 months
Quality of Life Measures: Role Physical (RP) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 year
Quality of Life Measures: Role Physical (RP) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 2 years
Quality of Life Measures: Role Physical (RP) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 3 years
Quality of Life Measures: Bodily Pain (BP) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 month
Quality of Life Measures: Bodily Pain (BP) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 6 months
Quality of Life Measures: Bodily Pain (BP) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 year
Quality of Life Measures: Bodily Pain (BP) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 2 years
Quality of Life Measures: Bodily Pain (BP) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 3 years
Quality of Life Measures: General Health (GH) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 month
Quality of Life Measures: General Health (GH) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 6 months
Quality of Life Measures: General Health (GH) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 year
Quality of Life Measures: General Health (GH) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 2 years
Quality of Life Measures: General Health (GH) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 3 years
Quality of Life Measures: Vitality (VT) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 month
Quality of Life Measures: Vitality (VT) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 6 months
Quality of Life Measures: Vitality (VT) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 year
Quality of Life Measures: Vitality (VT) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 2 years
Quality of Life Measures: Vitality (VT) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 3 years
Quality of Life Measures: Social Functioning (SF) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 month
Quality of Life Measures: Social Functioning (SF) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 6 months
Quality of Life Measures: Social Functioning (SF) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 year
Quality of Life Measures: Social Functioning (SF) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 2 years
Quality of Life Measures: Social Functioning (SF) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 3 years
Quality of Life Measures: Role Emotional (RE) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 month
Quality of Life Measures: Role Emotional (RE) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 6 months
Quality of Life Measures: Role Emotional (RE) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 year
Quality of Life Measures: Role Emotional (RE) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 2 years
Quality of Life Measures: Role Emotional (RE) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 3 years
Quality of Life Measures: Mental Health (MH) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 month
Quality of Life Measures: Mental Health (MH) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 6 months
Quality of Life Measures: Mental Health (MH) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 year
Quality of Life Measures: Mental Health (MH) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 2 years
Quality of Life Measures: Mental Health (MH) Summary
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 3 years
Quality of Life Measures: Physical Component Summary (PCS)
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 month
Quality of Life Measures: Physical Component Summary (PCS)
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 6 months
Quality of Life Measures: Physical Component Summary (PCS)
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 year
Quality of Life Measures: Physical Component Summary (PCS)
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 2 years
Quality of Life Measures: Mental Component Summary (MCS)
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 month
Quality of Life Measures: Physical Component Summary (PCS)
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 3 years
Quality of Life Measures: Mental Component Summary (MCS)
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 6 months
Quality of Life Measures: Mental Component Summary (MCS)
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 1 year
Quality of Life Measures: Mental Component Summary (MCS)
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 2 years
Quality of Life Measures: Mental Component Summary (MCS)
The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.
SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Measured: At 3 years
Vascular Quality of Life (VascuQol) Scores Summary
Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.
The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain.
Measured: At 1 month
Vascular Quality of Life (VascuQol) Scores Summary
Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.
The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain.
Measured: At 6 months
Vascular Quality of Life (VascuQol) Scores Summary
Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.
The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain.
Measured: At 1 year
Vascular Quality of Life (VascuQol) Scores Summary
Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.
The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain.
Measured: At 2 years
Vascular Quality of Life (VascuQol) Scores Summary
Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.
The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain.
Measured: At 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johannes Lammer, Prof. Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468974
- Sponsor's protocol ID
- 11-113
- Status last verified
- Feb 2018
- First submitted
- 2 Nov 2011
- Last updated
- 4 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lammer J, Bosiers M, Deloose K, Schmidt A, Zeller T, Wolf F, Lansink W, Sauguet A, Vermassen F, Lauwers G, Scheinert D, Popma JJ, McGreevy R, Rapoza R, Schwartz LB, Jaff MR. Bioresorbable Everolimus-Eluting Vascular Scaffold for Patients With Peripheral Artery Disease (ESPRIT I): 2-Year Clinical and Imaging Results. JACC Cardiovasc Interv. 2016 Jun 13;9(11):1178-87. doi: 10.1016/j.jcin.2016.02.051.
PubMed 27282601
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System for the Treatment of Subjects With Symptomatic Claudication From Occlusive Vascular Disease of the Superficial Femoral (SFA) or Common or External Iliac Arteries.
- ClinicalTrials.gov ID
- NCT01468974
- Acronym / sponsor ID
- 11-113
- Conditions
- Atherosclerosis, Peripheral Vascular Disease, Claudication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Nov 2011 (estimated)
- Results
- Posted 4 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESPRIT BVS | Other | Device: ESPRIT BVSSubjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Subject is ≥ 18 and ≤ 80 years of age at the time of signing informed consent.
- Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 1-3).
- For subjects with bilateral lesions, the higher Rutherford-Becker Clinical Category limb will be considered the target extremity to be treated in this trial.
- If both limbs are of the same Rutherford Becker Clinical Category, the target extremity will be selected based on investigator discretion.
- Subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and is able to provide informed consent.
Key exclusion criteria (38 listed)
- A platelet count <100,000 cells/mm3 or >700,000 cells/mm3; a white blood cell count (WBC) <3,000 cells/mm3; or hemoglobin < 10.0 g/dL
- Acute or chronic renal dysfunction (creatinine > 2.5 mg/dl or >176μmol/L)
- Severe liver impairment as defined by total bilirubin ≥ 3 mg/dl or two times increase over the normal level of serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT).
- Known allergies to the following: aspirin, clopidogrel, prasugrel or ticlopidine, heparin, contrast agent (that cannot be adequately premedicated), or drugs similar to everolimus (i.e. tacrolimus, sirolimus, zotarolimus) or other macrolides.
- Subject requires planned procedure that would necessitate the discontinuation of clopidogrel, prasugrel or ticlopidine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESPRIT BVSSubjects receiving ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries | Device | ESPRIT BVS |
Primary outcome
Device Success
Time frame: On Day 0 (From start of index procedure to end of index procedure)
Study device success is defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.
Technical Success
Time frame: On Day 0 (From start of index procedure to end of index procedure)
Technical success is defined on a per lesion basis, the attainment of a final residual stenosis of < 30% at the intended target lesion(s). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as technical success only if the above criteria are met.
Clinical Success
Time frame: > or = 2 days after the index procedure
Defined on a per subject basis, as the attainment of a final residual stenosis of < 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications* within 2 days after the index procedure or at hospital discharge, whichever is sooner. (Note that in the ESPRIT I study, only a single target lesion per subject is permitted to be treated). *Includes the following: Death; Amputation; Scaffold Thrombosis; Target Lesion Revascularization (by any percutaneous or surgical means); Target Vessel Revascularization (by any percutaneous or surgical means).
125 secondary outcomes
Number of Participants With Death
Time frame: 1 month
Number of Participants With Death
Time frame: 6 months
Number of Participants With Death
Time frame: 1 year
Number of Participants With Death
Time frame: 2 years
Number of Participants With Death
Time frame: 3 years
Number of Participants With Any Amputation of Treated Limb (Minor and Major)
Time frame: 1 month
Number of Participants With Any Amputation of Treated Limb (Minor and Major)
Time frame: 6 months
Number of Participants With Any Amputation of Treated Limb (Minor and Major)
Time frame: 1 year
Number of Participants With Any Amputation of Treated Limb (Minor and Major)
Time frame: 2 years
Number of Participants With Any Amputation of Treated Limb (Minor and Major)
Time frame: 3 years
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity
Time frame: 0 to 30 days
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity
Time frame: 0 to 180 days
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity
Time frame: 0 to 365 days
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity
Time frame: 0 to 730 days
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity
Time frame: 0 to 1095 days
Number of Participants With Scaffold Thrombosis
Time frame: 0 to 1 month
Scaffold Occlusion
Time frame: 1 month
Number of Participants With Scaffold Occlusion
Time frame: 6 months
Number of Participants With Scaffold Occlusion
Time frame: 1 year
Number of Participants With Scaffold Occlusion
Time frame: 2 years
Number of Participants With Scaffold Occlusion
Time frame: 0 to 3 years
Number of Participants With Target Lesion Revascularization (TLR)
Time frame: 1 month
Number of Participants With Target Lesion Revascularization (TLR)
Time frame: 6 months
Number of Participants With Target Lesion Revascularization (TLR)
Time frame: 1 year
Number of Participants With Target Lesion Revascularization (TLR)
Time frame: 2 years
Number of Participants With Target Lesion Revascularization (TLR)
Time frame: 3 years
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)
Time frame: 1 month
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)
Time frame: 6 months
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)
Time frame: 1 year
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)
Time frame: 2 years
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)
Time frame: 3 years
Number of Participants With Ipsilateral Extremity Revascularization (IER)
Time frame: 1 month
Number of Participants With Ipsilateral Extremity Revascularization (IER)
Time frame: 6 months
Number of Participants With Ipsilateral Extremity Revascularization (IER)
Time frame: 1 year
Number of Participants With Ipsilateral Extremity Revascularization (IER)
Time frame: 2 years
Number of Participants With Ipsilateral Extremity Revascularization (IER)
Time frame: 3 years
Number of Participants With Primary Patency
Time frame: 1 month
Number of Participants With Primary Patency
Time frame: 6 months
Number of Participants With Primary Patency
Time frame: 1 year
Number of Participants With Primary Patency
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27282601Lammer J, Bosiers M, Deloose K, Schmidt A, Zeller T, Wolf F, Lansink W, Sauguet A, Vermassen F, Lauwers G, Scheinert D, Popma JJ, McGreevy R, Rapoza R, Schwartz LB, Jaff MR. Bioresorbable Everolimus-Eluting Vascular Scaffold for Patients With Peripheral Artery Disease (ESPRIT I): 2-Year Clinical and Imaging Results. JACC Cardiovasc Interv. 2016 Jun 13;9(11):1178-87. doi: 10.1016/j.jcin.2016.02.051.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Lammer, Prof. Dr. principal investigator
Medical University of Vienna
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESPRIT BVS in people with Atherosclerosis and Peripheral Vascular Disease, run by Abbott Medical Devices at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, Germany, Austria, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Success (time frame: On Day 0 (From start of index procedure to end of index procedure)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01468974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.