Coronary DiseaseABSORB BNCT00856856
ABSORB Clinical Investigation, Cohort B
A study testing Bioabsorbable Everolimus Eluting Coronary Stent in people with Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 12 sites in 8 countries.
Trial summary
The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels. Currently in development at Abbott Vascular. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- What is being tested?
- Bioabsorbable Everolimus Eluting Coronary Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 12 sitesin 8 countries
- Study dates
- Mar 2009to Mar 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
General inclusion criteria
- Patient must be at least 18 years of age.
- Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the BVS Everolimus Eluting CSS and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
- Patient must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, intravascular ultrasound (IVUS), Palpography (optional), optical coherence tomography (OCT) (strongly recommended), multislice computed tomography (MSCT) (optional) and coronary vasomotion (optional)
- Patient must agree not to participate in any other clinical investigation for a period of two years following the index procedure
Angiographic Inclusion Criteria
- Target lesion(s) must be located in a native coronary artery with visually estimated nominal vessel diameter of 3.0 mm
- Target lesion(s) must measure ≤ 14 mm in length by visual estimation
- Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1
- If two target lesions meet the inclusion criteria they must be in different major epicardial vessels left anterior descending artery (LAD) with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches
- If two target lesion(s) are being treated, each of these lesions must meet all angiographic inclusion/exclusion criteria
- Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done ≥ 90 days prior to or if planned to be done 6 months after the index procedure
- Non-Clinical Investigation percutaneous intervention for lesion in the target vessel is allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure
General Exclusion Criteria
- Patients has had a known diagnosis of acute myocardial infarction (AMI) within 3 days preceding the index procedure and creatine kinase (CK) and CK-MB have not returned within normal limits at the time of procedure
- The patient is currently experiencing clinical symptoms consistent with AMI
- Patient has current unstable arrhythmias
- Patient has a known left ventricular ejection fraction (LVEF) < 30%
- Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
- Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
- Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
- Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
- Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, poly (L-lactide), poly (DL-lactide) or contrast sensitivity that cannot be adequately pre-medicated
- Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
- Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell count of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
- Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
- Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
- Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
- Patient has had a significant GI or urinary bleed within the past six months
- Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
- Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
- Patient is already participating in another clinical investigation that has not yet reached its primary endpoint
- Pregnant or nursing patients and those who plan pregnancy during the Clinical Investigation. (Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used during participation in this Clinical Investigation)
- Patient has received brachytherapy in any epicardial vessel (including side branches)
Angiographic Exclusion Criteria
- Target lesion(s) meets any of the following criteria:
- Aorto-ostial location (within 3 mm)
- Left main location
- Located within 2 mm of the origin of the LAD or LCX
- Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion, by visual estimation) arterial or saphenous vein graft
- Lesion involving a bifurcation ≥ 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation
- Total occlusion (TIMI flow 0), prior to wire crossing
- Excessive tortuosity proximal to or within the lesion
- Extreme angulation (≥ 90%) proximal to or within the lesion
- Heavy calcification
- Restenotic from previous intervention
- The target vessel contains visible thrombus
- Another clinically significant lesion is located in the same major epicardial vessel as the target lesion(s) (including side branches)
- Patient has a high probability that a procedure other than pre-dilatation and stenting and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)
Trial locations and contacts
12 sites in 8 countries.
12 sites in 8 countries
Netherlands3 sites
Catharina ZH Eindhoven
Eindhoven
Erasmus Medical Center
Rotterdam
Maasstad Ziekenhuis
Rotterdam
Australia2 sites
St. Vincent's Hospital
Melbourne, Victoria, 3065
Monash Heart
Melbourne
New Zealand2 sites
Auckland City Hospital
Auckland
Christchurch Hospital
Christchurch
About this study
Official title: A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With de Novo Native Coronary Artery Lesions.
The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels.
Currently in development at Abbott Vascular. Not available for sale in the United States.
- Being tested
- Bioabsorbable Everolimus Eluting Coronary Stent
- Keywords
- Bioabsorbable, Coronary Stent, Everolimus, Drug eluting stents, Stents, Angioplasty, Coronary artery disease (CAD), Total coronary occlusion, Coronary artery restenosis, Stent thrombosis, Vascular disease, Myocardial ischemia, Coronary artery stenosis
- Medical subject headings
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Vascular Diseases, Myocardial Ischemia, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioabsorbable Everolimus Eluting Coronary StentDevice
Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
| Study group | Role | What they receive |
|---|---|---|
| Absorb stent | Experimental | Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) Receives: Device: Bioabsorbable Everolimus Eluting Coronary Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical Major Adverse Cardiac Event (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Measured: 30 days
Hierarchical Major Adverse Cardiac Event (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Measured: 1 year
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days
In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Measured: 180 days
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year
In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up
Measured: 1 year
Secondary outcomes (101)
Clinical Device Success (Per Lesion)
Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as device success only if the above criteria for clinical device are met.
Measured: On day 0 (the day of procedure)
Clinical Procedure Success (Per Patient)
Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia-driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.
Measured: On day 0 (the day of procedure)
Hierarchical Major Adverse Cardiac Event (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Measured: 180 days
Hierarchical Major Adverse Cardiac Event (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Measured: 270 days
Hierarchical Major Adverse Cardiac Event (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Measured: 2 years
Hierarchical Major Adverse Cardiac Event (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Measured: 3 years
Hierarchical Major Adverse Cardiac Event (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Measured: 4 years
Hierarchical Major Adverse Cardiac Event (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Measured: 5 years
Hierarchical Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 30 days
Hierarchical Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 180 days
Hierarchical Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 270 days
Hierarchical Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 1 year
Hierarchical Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 2 years
Hierarchical Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 3 years
Hierarchical Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 4 years
Hierarchical Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 5 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 30 days
Ischemia Driven Target Lesion Revascularization (ID-TLR)
ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 180 days
Ischemia Driven Target Lesion Revascularization (ID-TLR)
ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 270 days
Ischemia Driven Target Lesion Revascularization (ID-TLR)
ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 1 year
Ischemia Driven Target Lesion Revascularization (ID-TLR)
ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 2 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 3 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 4 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
ID-TLR is defined as the revascularization at the target lesion associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 5 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
ID-TVR is the revascularization in the target vessel associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 30 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
ID-TVR is the revascularization in the target vessel associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 180 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
ID-TVR is the revascularization in the target vessel associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 270 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
ID-TVR is the revascularization in the target vessel associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 1 year
Ischemia Driven Target Vessel Revascularization (ID-TVR)
ID-TVR is the revascularization in the target vessel associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 2 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
ID-TVR is the revascularization in the target vessel associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 3 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
ID-TVR is the revascularization in the target vessel associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 4 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
ID-TVR is the revascularization in the target vessel associated with any of the following:
- Positive functional ischemia study
- Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
- Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 5 years
Cardiac 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.)
Measured: 30 days
Cardiac 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.)
Measured: 1 year
Cardiac 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.)
Measured: 2 years
Cardiac 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.)
Measured: 3 years
Cardiac 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.)
Measured: 4 years
Cardiac 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.)
Measured: 5 years
Myocardial Infarction
Myocardial Infarction (MI):
- Q wave MI: Development of new, pathological Q wave on the ECG.
- Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Measured: 30 days
Myocardial Infarction
Myocardial Infarction (MI):
- Q wave MI: Development of new, pathological Q wave on the ECG.
- Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Measured: 1 year
Myocardial Infarction
Myocardial Infarction (MI):
- Q wave MI: Development of new, pathological Q wave on the ECG.
- Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Measured: 2 years
Myocardial Infarction
Myocardial Infarction (MI):
- Q wave MI: Development of new, pathological Q wave on the ECG.
- Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Measured: 3 years
Myocardial Infarction
Myocardial Infarction (MI):
- Q wave MI: Development of new, pathological Q wave on the ECG.
- Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Measured: 4 years
Myocardial Infarction
Myocardial Infarction (MI):
- Q wave MI: Development of new, pathological Q wave on the ECG.
- Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Measured: 5 years
Scaffold Thrombosis
Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:
- Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
- In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Measured: 30 days
Scaffold Thrombosis
Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:
- Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
- In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Measured: 1 year
Scaffold Thrombosis
Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:
- Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
- In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Measured: 2 years
Scaffold Thrombosis
Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:
- Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
- In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Measured: 3 years
Scaffold Thrombosis
Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:
- Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
- In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Measured: 4 years
Scaffold Thrombosis
Scaffold thrombosis will be categorized as acute (≤ 1day), subacute (>1day ≤ 30 days) and late (>30 days) and will be defined as any of the following:
- Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion)
- In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific ST /T changes and cardiac enzyme elevations do not suffice)
Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Measured: 5 years
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 2 Years
In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Measured: 2 years
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 3 Years
In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Measured: 3 years
In-scaffold Late Loss (LL): In-scaffold MLD Post-procedure - In-scaffold MLD at 5 Years
In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
Measured: 5 years
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 180 Days
Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Measured: 180 days
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 1 Year
Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Measured: 1 year
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 2 Years
Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Measured: 2 years
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 3 Years
Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Measured: 3 years
Proximal Late Loss: Proximal MLD Post-procedure - Proximal MLD at 5 Years
Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to scaffold placement).
Measured: 5 years
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 180 Days
Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Measured: 180 days
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 1 Year
Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Measured: 1 year
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 2 Years
Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Measured: 2 years
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 3 Years
Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Measured: 3 years
Distal Late Loss: Distal MLD Post-procedure - Distal MLD at 5 Years
Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to scaffold placement).
Measured: 5 years
In-scaffold Angiographic Binary Restenosis (ABR)
Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Measured: 180 days
In-scaffold Angiographic Binary Restenosis (ABR)
Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Measured: 1 year
In-scaffold Angiographic Binary Restenosis (ABR)
Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Measured: 2 years
In-scaffold Angiographic Binary Restenosis (ABR)
Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Measured: 3 years
In-scaffold Angiographic Binary Restenosis (ABR)
Percent of patients with a followup percent diameter stenosis of >=50% per QCA.
Measured: 5 years
Persisting Dissection
Dissection at follow-up that was present post-procedure.
Measured: 180 days
Persisting Dissection
Dissection at follow-up that was present post-procedure.
Measured: 1 year
Persisting Dissection
Dissection at follow-up that was present post-procedure.
Measured: 2 years
Persisting Dissection
Dissection at follow-up that was present post-procedure.
Measured: 3 years
Persisting Dissection
Dissection at follow-up that was present post-procedure.
Measured: 5 years
In-scaffold Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Measured: 180 days
In-scaffold Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Measured: 1 year
In-scaffold Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Measured: 2 years
In-scaffold Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Measured: 3 years
In-scaffold Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Measured: 5 years
Aneurysm
An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Measured: 180 days
Aneurysm
An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Measured: 1 year
Aneurysm
An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Measured: 2 years
Aneurysm
An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Measured: 3 years
Aneurysm
An abnormal expansion or protrusion of a coronary blood vessel resulting from a disease or weakening of the vessel's wall (all three layers) that exceeds the RVD of the vessel by 1.5 times.
Measured: 5 years
Thrombus
Measured: 180 days
Thrombus
Measured: 1 year
Thrombus
Measured: 2 years
Thrombus
Measured: 3 years
Thrombus
Measured: 5 years
Vasomotion Analysis: In-scaffold Mean Luminal Diameter
Vasomotion function was assessed in reaction to nitrate administration.
Measured: 5 years
Volume Obstruction (VO)
Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Measured: 180 days
Volume Obstruction (VO)
Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Measured: 1 year
Volume Obstruction (VO)
Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Measured: 2 year
Volume Obstruction (VO)
Defined as scaffold intimal hyperplasia and calculated as 100*(Scaffold Volume - Lumen Volume)/Scaffold Volume by IVUS.
Measured: 3 year
Persisting Incomplete Apposition
Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Measured: 180 days
Persisting Incomplete Apposition
Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Measured: 1 year
Persisting Incomplete Apposition
Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Measured: 2 year
Persisting Incomplete Apposition
Persisting incomplete apposition is defined as incomplete apposition at follow-up that was present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Measured: 3 year
Late Incomplete Apposition
Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Measured: 180 days
Late Incomplete Apposition
Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Measured: 1 year
Late Incomplete Apposition
Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Measured: 2 year
Late Incomplete Apposition
Late-Acquired Incomplete Apposition is defined as incomplete apposition of the scaffold at follow-up, which was not present post-procedure.
Incomplete Apposition: Failure of the scaffold to completely appose to the vessel wall after placement is defined as one or more scaffold strut separated from the vessel wall with evidence of blood speckles behind the strut in the ultrasound image.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2015
- Study completionMar 2016
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 (22)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Serruys, MD, Principal investigator, Erasmus Heart Center, Thorax CentrumJohn Ormiston, MD, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856856
- Sponsor's protocol ID
- 05-370 Cohort B
- Acronym
- ABSORB B
- Status last verified
- Jan 2018
- First submitted
- 27 Feb 2009
- Last updated
- 7 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Zeng Y, Cavalcante R, Collet C, Tenekecioglu E, Sotomi Y, Miyazaki Y, Katagiri Y, Asano T, Abdelghani M, Nie S, Bourantas CV, Bruining N, Onuma Y, Serruys PW. Coronary calcification as a mechanism of plaque/media shrinkage in vessels treated with bioresorbable vascular scaffold: A multimodality intracoronary imaging study. Atherosclerosis. 2018 Feb;269:6-13. doi: 10.1016/j.atherosclerosis.2017.11.002. Epub 2017 Dec 2.
PubMed 29247976Onuma Y, Grundeken MJ, Nakatani S, Asano T, Sotomi Y, Foin N, Ng J, Okamura T, Wykrzykowska JJ, de Winter RJ, van Geuns RJ, Koolen J, Christiansen EH, Whitbourn R, McClean D, Smits P, Windecker S, Ormiston JA, Serruys PW. Serial 5-Year Evaluation of Side Branches Jailed by Bioresorbable Vascular Scaffolds Using 3-Dimensional Optical Coherence Tomography: Insights From the ABSORB Cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). Circ Cardiovasc Interv. 2017 Sep;10(9):e004393. doi: 10.1161/CIRCINTERVENTIONS.116.004393.
PubMed 28893770Zeng Y, Tateishi H, Cavalcante R, Tenekecioglu E, Suwannasom P, Sotomi Y, Collet C, Nie S, Jonker H, Dijkstra J, Radu MD, Raber L, McClean DR, van Geuns RJ, Christiansen EH, Fahrni T, Koolen J, Onuma Y, Bruining N, Serruys PW. Serial Assessment of Tissue Precursors and Progression of Coronary Calcification Analyzed by Fusion of IVUS and OCT: 5-Year Follow-Up of Scaffolded and Nonscaffolded Arteries. JACC Cardiovasc Imaging. 2017 Oct;10(10 Pt A):1151-1161. doi: 10.1016/j.jcmg.2016.11.016. Epub 2017 Mar 15.
PubMed 28330651Onuma Y, Collet C, van Geuns RJ, de Bruyne B, Christiansen E, Koolen J, Smits P, Chevalier B, McClean D, Dudek D, Windecker S, Meredith I, Nieman K, Veldhof S, Ormiston J, Serruys PW; ABSORB Investigators. Long-term serial non-invasive multislice computed tomography angiography with functional evaluation after coronary implantation of a bioresorbable everolimus-eluting scaffold: the ABSORB cohort B MSCT substudy. Eur Heart J Cardiovasc Imaging. 2017 May 1;18(8):870-879. doi: 10.1093/ehjci/jex022.
PubMed 28329198Serruys PW, Ormiston J, van Geuns RJ, de Bruyne B, Dudek D, Christiansen E, Chevalier B, Smits P, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Wasungu L, Ediebah D, Veldhof S, Onuma Y. A Polylactide Bioresorbable Scaffold Eluting Everolimus for Treatment of Coronary Stenosis: 5-Year Follow-Up. J Am Coll Cardiol. 2016 Feb 23;67(7):766-76. doi: 10.1016/j.jacc.2015.11.060.
PubMed 26892411Ishibashi Y, Nakatani S, Sotomi Y, Suwannasom P, Grundeken MJ, Garcia-Garcia HM, Bartorelli AL, Whitbourn R, Chevalier B, Abizaid A, Ormiston JA, Rapoza RJ, Veldhof S, Onuma Y, Serruys PW. Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II). JACC Cardiovasc Interv. 2015 Nov;8(13):1715-26. doi: 10.1016/j.jcin.2015.07.026.
PubMed 26585622Karanasos A, Garcia-Garcia HM, van Geuns RJ, Regar E. Fate of side-branch jailing and a malapposed platinum marker after resorption of an everolimus-eluting bioresorbable vascular scaffold: serial optical coherence tomography observations. JACC Cardiovasc Interv. 2015 Mar;8(3):e53-e54. doi: 10.1016/j.jcin.2014.10.020. No abstract available.
PubMed 25790767Onuma Y, Serruys PW, Muramatsu T, Nakatani S, van Geuns RJ, de Bruyne B, Dudek D, Christiansen E, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Garcia-Garcia HM, Veldhof S, Rapoza R, Ormiston JA. Incidence and imaging outcomes of acute scaffold disruption and late structural discontinuity after implantation of the absorb Everolimus-Eluting fully bioresorbable vascular scaffold: optical coherence tomography assessment in the ABSORB cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2014 Dec;7(12):1400-11. doi: 10.1016/j.jcin.2014.06.016.
PubMed 25523532Zhang YJ, Iqbal J, Nakatani S, Bourantas CV, Campos CM, Ishibashi Y, Cho YK, Veldhof S, Wang J, Onuma Y, Garcia-Garcia HM, Dudek D, van Geuns RJ, Serruys PW; ABSORB Cohort B Study Investigators. Scaffold and edge vascular response following implantation of everolimus-eluting bioresorbable vascular scaffold: a 3-year serial optical coherence tomography study. JACC Cardiovasc Interv. 2014 Dec;7(12):1361-9. doi: 10.1016/j.jcin.2014.06.025. Epub 2014 Nov 12.
PubMed 25457053Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.
PubMed 24746650Serruys PW, Onuma Y, Garcia-Garcia HM, Muramatsu T, van Geuns RJ, de Bruyne B, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Rapoza R, Ormiston JA. Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months. EuroIntervention. 2014 Mar 20;9(11):1271-84. doi: 10.4244/EIJV9I11A217.
PubMed 24291783Ormiston JA, Serruys PW, Onuma Y, van Geuns RJ, de Bruyne B, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Rapoza R, Garcia-Garcia HM. First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study. Circ Cardiovasc Interv. 2012 Oct;5(5):620-32. doi: 10.1161/CIRCINTERVENTIONS.112.971549. Epub 2012 Oct 9.
PubMed 23048057Gutierrez-Chico JL, Gijsen F, Regar E, Wentzel J, de Bruyne B, Thuesen L, Ormiston J, McClean DR, Windecker S, Chevalier B, Dudek D, Whitbourn R, Brugaletta S, Onuma Y, Serruys PW. Differences in neointimal thickness between the adluminal and the abluminal sides of malapposed and side-branch struts in a polylactide bioresorbable scaffold: evidence in vivo about the abluminal healing process. JACC Cardiovasc Interv. 2012 Apr;5(4):428-35. doi: 10.1016/j.jcin.2011.12.015.
PubMed 22516401Brugaletta S, Radu MD, Garcia-Garcia HM, Heo JH, Farooq V, Girasis C, van Geuns RJ, Thuesen L, McClean D, Chevalier B, Windecker S, Koolen J, Rapoza R, Miquel-Hebert K, Ormiston J, Serruys PW. Circumferential evaluation of the neointima by optical coherence tomography after ABSORB bioresorbable vascular scaffold implantation: can the scaffold cap the plaque? Atherosclerosis. 2012 Mar;221(1):106-12. doi: 10.1016/j.atherosclerosis.2011.12.008. Epub 2011 Dec 13.
PubMed 22209268Gutierrez-Chico JL, Radu MD, Diletti R, Sheehy A, Kossuth MB, Oberhauser JP, Glauser T, Harrington J, Rapoza RJ, Onuma Y, Serruys PW. Spatial distribution and temporal evolution of scattering centers by optical coherence tomography in the poly(L-lactide) backbone of a bioresorbable vascular scaffold. Circ J. 2012;76(2):342-50. doi: 10.1253/circj.cj-11-0726. Epub 2011 Nov 19.
PubMed 22104034
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With de Novo Native Coronary Artery Lesions.
- ClinicalTrials.gov ID
- NCT00856856
- Acronym / sponsor ID
- ABSORB B / 05-370 Cohort B
- Keywords
- Bioabsorbable, Coronary Stent, Everolimus, Drug eluting stents, Stents, Angioplasty, Coronary artery disease (CAD), Total coronary occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Oct 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Mar 2009 (estimated)
- Results
- Posted 7 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 this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels.
Currently in development at Abbott Vascular. Not available for sale in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Absorb stent | Experimental | Device: Bioabsorbable Everolimus Eluting Coronary StentBioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Bioabsorbable Everolimus Eluting Coronary StentBioabsorbable drug eluting stent implantation in the treatment of coronary artery disease | Device | Absorb stent |
Primary outcome
Hierarchical Major Adverse Cardiac Event (MACE)
Time frame: 30 days
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
Hierarchical Major Adverse Cardiac Event (MACE)
Time frame: 1 year
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction,and clinically indicated target lesion revascularization (CI-TLR).
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 180 Days
Time frame: 180 days
In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up.
In-scaffold Late Loss: In-scaffold MLD Post-procedure - In-scaffold MLD at 1 Year
Time frame: 1 year
In-scaffold Late Loss: in-scaffold MLD post-procedure - in-scaffold MLD at follow-up
101 secondary outcomes
Clinical Device Success (Per Lesion)
Time frame: On day 0 (the day of procedure)
Clinical Procedure Success (Per Patient)
Time frame: On day 0 (the day of procedure)
Hierarchical Major Adverse Cardiac Event (MACE)
Time frame: 180 days
Hierarchical Major Adverse Cardiac Event (MACE)
Time frame: 270 days
Hierarchical Major Adverse Cardiac Event (MACE)
Time frame: 2 years
Hierarchical Major Adverse Cardiac Event (MACE)
Time frame: 3 years
Hierarchical Major Adverse Cardiac Event (MACE)
Time frame: 4 years
Hierarchical Major Adverse Cardiac Event (MACE)
Time frame: 5 years
Hierarchical Target Vessel Failure (TVF)
Time frame: 30 days
Hierarchical Target Vessel Failure (TVF)
Time frame: 180 days
Hierarchical Target Vessel Failure (TVF)
Time frame: 270 days
Hierarchical Target Vessel Failure (TVF)
Time frame: 1 year
Hierarchical Target Vessel Failure (TVF)
Time frame: 2 years
Hierarchical Target Vessel Failure (TVF)
Time frame: 3 years
Hierarchical Target Vessel Failure (TVF)
Time frame: 4 years
Hierarchical Target Vessel Failure (TVF)
Time frame: 5 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 30 days
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 180 days
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 270 days
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 1 year
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 2 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 3 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 4 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 5 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 30 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 180 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 270 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 1 year
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 2 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 3 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 4 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 5 years
Cardiac Death
Time frame: 30 days
Cardiac Death
Time frame: 1 year
Cardiac Death
Time frame: 2 years
Cardiac Death
Time frame: 3 years
Cardiac Death
Time frame: 4 years
Cardiac Death
Time frame: 5 years
Myocardial Infarction
Time frame: 30 days
Myocardial Infarction
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29247976Zeng Y, Cavalcante R, Collet C, Tenekecioglu E, Sotomi Y, Miyazaki Y, Katagiri Y, Asano T, Abdelghani M, Nie S, Bourantas CV, Bruining N, Onuma Y, Serruys PW. Coronary calcification as a mechanism of plaque/media shrinkage in vessels treated with bioresorbable vascular scaffold: A multimodality intracoronary imaging study. Atherosclerosis. 2018 Feb;269:6-13. doi: 10.1016/j.atherosclerosis.2017.11.002. Epub 2017 Dec 2.
- Derived from this study: PubMed 28893770Onuma Y, Grundeken MJ, Nakatani S, Asano T, Sotomi Y, Foin N, Ng J, Okamura T, Wykrzykowska JJ, de Winter RJ, van Geuns RJ, Koolen J, Christiansen EH, Whitbourn R, McClean D, Smits P, Windecker S, Ormiston JA, Serruys PW. Serial 5-Year Evaluation of Side Branches Jailed by Bioresorbable Vascular Scaffolds Using 3-Dimensional Optical Coherence Tomography: Insights From the ABSORB Cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). Circ Cardiovasc Interv. 2017 Sep;10(9):e004393. doi: 10.1161/CIRCINTERVENTIONS.116.004393.
- Derived from this study: PubMed 28330651Zeng Y, Tateishi H, Cavalcante R, Tenekecioglu E, Suwannasom P, Sotomi Y, Collet C, Nie S, Jonker H, Dijkstra J, Radu MD, Raber L, McClean DR, van Geuns RJ, Christiansen EH, Fahrni T, Koolen J, Onuma Y, Bruining N, Serruys PW. Serial Assessment of Tissue Precursors and Progression of Coronary Calcification Analyzed by Fusion of IVUS and OCT: 5-Year Follow-Up of Scaffolded and Nonscaffolded Arteries. JACC Cardiovasc Imaging. 2017 Oct;10(10 Pt A):1151-1161. doi: 10.1016/j.jcmg.2016.11.016. Epub 2017 Mar 15.
- Derived from this study: PubMed 28329198Onuma Y, Collet C, van Geuns RJ, de Bruyne B, Christiansen E, Koolen J, Smits P, Chevalier B, McClean D, Dudek D, Windecker S, Meredith I, Nieman K, Veldhof S, Ormiston J, Serruys PW; ABSORB Investigators. Long-term serial non-invasive multislice computed tomography angiography with functional evaluation after coronary implantation of a bioresorbable everolimus-eluting scaffold: the ABSORB cohort B MSCT substudy. Eur Heart J Cardiovasc Imaging. 2017 May 1;18(8):870-879. doi: 10.1093/ehjci/jex022.
- Derived from this study: PubMed 26892411Serruys PW, Ormiston J, van Geuns RJ, de Bruyne B, Dudek D, Christiansen E, Chevalier B, Smits P, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Wasungu L, Ediebah D, Veldhof S, Onuma Y. A Polylactide Bioresorbable Scaffold Eluting Everolimus for Treatment of Coronary Stenosis: 5-Year Follow-Up. J Am Coll Cardiol. 2016 Feb 23;67(7):766-76. doi: 10.1016/j.jacc.2015.11.060.
- Derived from this study: PubMed 26585622Ishibashi Y, Nakatani S, Sotomi Y, Suwannasom P, Grundeken MJ, Garcia-Garcia HM, Bartorelli AL, Whitbourn R, Chevalier B, Abizaid A, Ormiston JA, Rapoza RJ, Veldhof S, Onuma Y, Serruys PW. Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II). JACC Cardiovasc Interv. 2015 Nov;8(13):1715-26. doi: 10.1016/j.jcin.2015.07.026.
- Derived from this study: PubMed 25790767Karanasos A, Garcia-Garcia HM, van Geuns RJ, Regar E. Fate of side-branch jailing and a malapposed platinum marker after resorption of an everolimus-eluting bioresorbable vascular scaffold: serial optical coherence tomography observations. JACC Cardiovasc Interv. 2015 Mar;8(3):e53-e54. doi: 10.1016/j.jcin.2014.10.020. No abstract available.
- Derived from this study: PubMed 25523532Onuma Y, Serruys PW, Muramatsu T, Nakatani S, van Geuns RJ, de Bruyne B, Dudek D, Christiansen E, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Garcia-Garcia HM, Veldhof S, Rapoza R, Ormiston JA. Incidence and imaging outcomes of acute scaffold disruption and late structural discontinuity after implantation of the absorb Everolimus-Eluting fully bioresorbable vascular scaffold: optical coherence tomography assessment in the ABSORB cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2014 Dec;7(12):1400-11. doi: 10.1016/j.jcin.2014.06.016.
- Derived from this study: PubMed 25457053Zhang YJ, Iqbal J, Nakatani S, Bourantas CV, Campos CM, Ishibashi Y, Cho YK, Veldhof S, Wang J, Onuma Y, Garcia-Garcia HM, Dudek D, van Geuns RJ, Serruys PW; ABSORB Cohort B Study Investigators. Scaffold and edge vascular response following implantation of everolimus-eluting bioresorbable vascular scaffold: a 3-year serial optical coherence tomography study. JACC Cardiovasc Interv. 2014 Dec;7(12):1361-9. doi: 10.1016/j.jcin.2014.06.025. Epub 2014 Nov 12.
- Derived from this study: PubMed 24746650Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.
- Derived from this study: PubMed 24291783Serruys PW, Onuma Y, Garcia-Garcia HM, Muramatsu T, van Geuns RJ, de Bruyne B, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Rapoza R, Ormiston JA. Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months. EuroIntervention. 2014 Mar 20;9(11):1271-84. doi: 10.4244/EIJV9I11A217.
- Derived from this study: PubMed 23048057Ormiston JA, Serruys PW, Onuma Y, van Geuns RJ, de Bruyne B, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Rapoza R, Garcia-Garcia HM. First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study. Circ Cardiovasc Interv. 2012 Oct;5(5):620-32. doi: 10.1161/CIRCINTERVENTIONS.112.971549. Epub 2012 Oct 9.
- Absorb, cohort ALink provided by the sponsor.
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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.
Patrick Serruys, MD principal investigator
Erasmus Heart Center, Thorax Centrum
John Ormiston, MD principal investigator
Auckland City Hospital
12 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioabsorbable Everolimus Eluting Coronary Stent in people with Coronary Disease and Coronary Artery Disease, run by Abbott Medical Devices at 12 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 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 12 sites in Netherlands, Australia, New Zealand, Belgium, Denmark and 3 more countries. 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 7 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?
Hierarchical Major Adverse Cardiac Event (MACE) (time frame: 30 days). The study lists 4 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 NCT00856856, which also lists 22 linked publications.
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 7 Feb 2019.