Coronary Artery DiseaseSPIRIT SVNCT00783796
SPIRIT Small Vessel Registry
A study testing 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System in people with Coronary Artery Disease and Atherosclerosis, run by Abbott Medical Devices at 34 sites in United States.
Trial summary
To evaluate the safety and effectiveness of the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions in small vessels, each in a different epicardial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis, Myocardial Ischemia
- What is being tested?
- 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 34 sitesUnited States
- Study dates
- Oct 2008to Dec 2013
- 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
- Subject must be at least 18 years of age.
- Subject or a legally authorized representative must provide written informed consent prior to any study related procedure.
- Subject 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).
- Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.
Angiographic Inclusion Criteria
- One target or two (two target or one target and one non-target) de novo lesion(s), each in a different epicardial vessel.
- If there are two target lesions or one target and one non-target lesion, both lesions must satisfy the angiographic eligibility criteria.
- The target lesion(s) or non-target lesion must be located in a major artery or branch with a visually estimated diameter stenosis of ≥50% and < 100% with a TIMI flow of ≥1.
- The target lesion(s) or non-target lesion must be located in a native coronary artery with a reference vessel diameter by visual estimation of: Target Lesion: ≥ 2.25 mm to < 2.5 mm for treatment by the 2.25 mm XIENCE V® EECS. Non-target Lesion: ≥2.5 mm to ≤4.25 mm for treatment by the commercial XIENCE V® EECS.
- The target lesion(s) or non-target lesion must be located in a native coronary artery with a lesion length by visual estimation of ≤28 mm.
General Exclusion Criteria
- Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB (creatine kinase myocardial-band isoenzyme) ≥2 times the upper limit of normal) and CK and CK-MB levels have not returned to within normal limits at the time of procedure.
- The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
- Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.
- Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
- Subject has received coronary brachytherapy in any epicardial vessel.
- Subject has received any organ transplant or is on a waiting list for any organ transplant.
- Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
- Subject is receiving or scheduled to receive planned radiation therapy to the chest or mediastinum.
- Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).
- Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
- Subjects who will require Low Molecular Weight Heparin (LMWH) post-procedure.
- Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoropolymers or contrast sensitivity that cannot be adequately pre-medicated.
- Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel.
- Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC (white blood cell) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
- Subject has known renal insufficiency (eg, serum creatinine level ≥ 2.5 mg/dL, or on dialysis).
- Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
- Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.
- Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
- Subject 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 protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
- Subject is currently participating in another clinical study that has not yet completed its primary endpoint.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Angiographic Exclusion Criteria
- Target lesion(s) or non-target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
- Target lesion(s) or non-target lesion involving a bifurcation with a side branch ≥2 mm in diameter and/or ostial lesion > 40% stenosed by visual estimation or side branch requiring protection guide wire, or side branch requiring dilatation.
- Total occlusion (TIMI flow 0), prior to crossing with the wire.
- Another lesion requiring revascularization is located in the same epicardial vessel of either the target or non-target lesion.
- Restenotic lesion.
- Aorto-ostial lesion (within 3 mm of the aorta junction).
- Left main location.
- Lesion located within 2 mm of the origin of the LAD (left anterior descending) or LCX (left coronary artery)
- Extreme angulation (≥90°) or excessive tortuosity (≥ two 45° angles) proximal to or within the target or non-target lesion.
- Heavy calcification proximal to or within the target or non-target lesion(s).
- Target or non-target vessel contains thrombus as indicated in the angiographic images.
- Target lesion(s) or non-target lesion have a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treating the target and non-target vessel(s) (e.g. atherectomy, cutting balloon).
- Target or non-target vessel(s) have previously been treated with percutaneous intervention (e.g. balloon angioplasty, stent, cutting balloon, atherectomy) < 9 months prior to index procedure.
- A vessel not intended to be treated with a 2.25 mm XIENCE V® EECS or commercial sizes of XIENCE V® EECS that was previously treated with any type of PCI (percutaneous coronary intervention) < 90 days prior to the index procedure.
- Additional clinically significant lesion(s) (e.g., %DS (diameter stenosis) ≥ 50%) is present in any vessel or side branch for which PCI may be required < 90 days after the index procedure.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Northwest Texas Healthcare System
Amarillo, Texas, 79106
Union Memorial Hospital
Baltimore, Maryland, 21218
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Overlake Hospital Medical Center
Bellevue, Washington, 98004
St. Joseph Hospital
Bellingham, Washington, 98225
Cooper Health System
Camden, New Jersey, 08103
Carolinas Medical Center
Charlotte, North Carolina, 28203
Presbyterian Hospital
Charlotte, North Carolina, 28204
The Christ Hospital
Cincinnati, Ohio, 45219
Morton Plant Hospital
Clearwater, Florida, 33756
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Riverside Methodist Hospital
Columbus, Ohio, 43214
Geisinger Medical Center
Danville, Pennsylvania, 17822
EMH Regional Medical Center
Elyria, Ohio, 44035
Baptist West Hospital
Knoxville, Tennessee, 37934
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
St. Patrick Hospital
Missoula, Montana, 59802
Gotham Cardiovascular Reasearch, PC. (St. Vincent's Medical Center-closing, pts moved)
New York, New York, 10011
Sacred Heart Hospital
Pensacola, Florida, 32504-8721
Northern Michigan Hospital
Petoskey, Michigan, 49770
WakeMed Hospital
Raleigh, North Carolina, 27610
St. Anthony Hospital
Rockford, Illinois, 61107
St. Cloud Hospital
Saint Cloud, Minnesota, 56303
Scottsdale Healthcare
Scottsdale, Arizona, 85260
Sanford USD Medical Center
Sioux Falls, South Dakota, 57104
St. John's Hospital / Prairie Education & Research Cooperative
Springfield, Illinois, 62769
Baystate Medical Center
Springfield, Massachusetts, 01199
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608
St. Joseph Medical Center
Towson, Maryland, 21204
Hillcrest Medical Center
Tulsa, Oklahoma, 74104
Mother Frances Hospital
Tyler, Texas, 75701
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
St. Joseph Mercy Hospital
Ypsilanti, Michigan, 48197
About this study
Official title: Spirit Small Vessel Registry (SPIRIT SV)
To evaluate the safety and effectiveness of the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions in small vessels, each in a different epicardial vessel.
- Being tested
- 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System
- Keywords
- Coronary artery disease, Atherosclerosis, Myocardial ischemia
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.25 mm XIENCE V® Everolimus Eluting Coronary Stent SystemDevice
Treatment of a maximum of two de novo native coronary artery lesions in small vessels.
| Study group | Role | What they receive |
|---|---|---|
| 2.25mm XIENCE V® | Experimental | Patients receiving the 2.25 mm XIENCE V® stent Receives: Device: 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).
This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.
Measured: 1 year
Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).
This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.
Measured: 2 years
Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).
This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.
Measured: 3 years
Secondary outcomes (96)
Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)
Successful delivery and deployment of the first study stent intended to be implanted at the intended target lesion (or intended first and second investigational stents for overlapping stents), successful withdrawal of the stent delivery system, and attainment of final residual stenosis of <50%.
Measured: From start of index procedure to end of index procedure
Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)
Achievement of a final in-stent diameter stenosis of <50% using the study device, without the occurence of cardiac death, target vessel myocardial infarction per protocol definition, or repeat revascularization of the target lesion during the hospital stay up to 7 days.
Measured: From the start of index procedure to end of index procedure
In-Stent Late Loss
In-stent minimum lumen diameter (MLD) post-procedure minus in-stent MLD at angiographic follow-up.
Measured: 240 days
In-segment Late Loss (LL)
In-segment minimum lumen diameter (MLD) post-procedure minus in-segment MLD at angiographic follow-up.
Measured: 240 Days
Proximal Late Loss
Proximal minimum lumen diameter (MLD) post-procedure minus proximal MLD at angiographic follow-up (proximal defined as 5 mm of healthy tissue proximal to stent placement).
Measured: 240 days
Distal Late Loss
Distal minimum lumen diameter (MLD) post-procedure minus distal MLD at angiographic follow-up (distal defined as 5 mm of healthy tissue distal to stent placement).
Measured: 240 days
In-stent % Diameter Stenosis
Value calculated as 100*(1-MLD/RVD) where MLD is in-stent minimum lumen diameter and RVD is in-stent reference vessel diameter.
Measured: 240 days
In-segment % Diameter Stenosis
Value calculated as 100*(1-MLD/RVD) where MLD is in-segment minimum lumen diameter and RVD is in-segment reference vessel diameter.
Measured: 240 days
Proximal % Diameter Stenosis
Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue proximal to stent placement.
Measured: 240 days
Distal % Diameter Stenosis
Value calculated as 100*(1-MLD/RVD) where MLD is minimum lumen diameter and RVD is reference vessel diameter in 5 mm of healthy tissue distal to stent placement.
Measured: 240 days
In-stent Angiographic Binary Restenosis (ABR) Rate
Percentage of patients with target lesions with ≥ 50% in-stent % diameter stenosis at angiographic follow-up.
Measured: 240 days
In-segment Angiographic Binary Restenosis (ABR) Rate
Percentage of patients with target lesions with ≥ 50% in-segment % diameter stenosis at angiographic follow-up.
Measured: 240 days
Proximal Angiographic Binary Restenosis (ABR) Rate
Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue proximal to stent placement at angiographic follow-up.
Measured: 240 days
Distal Angiographic Binary Restenosis (ABR) Rate
Percentage of patients with target lesions with ≥ 50% diameter stenosis in 5 mm of healthy tissue distal to stent placement at angiographic follow-up.
Measured: 240 days
All Death (Cardiac, Vascular, Non-cardiovascular)
All death, including death from cardiac, vascular, and non-cardiovascular causes.
Measured: 30 days
All Death (Cardiac, Vascular, Non-cardiovascular)
All death, including death from cardiac, vascular, and non-cardiovascular causes.
Measured: 240 days
All Death (Cardiac, Vascular, Non-cardiovascular)
All death, including death from cardiac, vascular, and non-cardiovascular causes.
Measured: 1 year
All Death (Cardiac, Vascular, Non-cardiovascular)
All death, including death from cardiac, vascular, and non-cardiovascular causes.
Measured: 2 years
All Death (Cardiac, Vascular, Non-cardiovascular)
All death, including death from cardiac, vascular, and non-cardiovascular causes (per protocol).
Measured: 3 years
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Measured: 30 days
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Measured: 240 days
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Measured: 1 year
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Measured: 2 years
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
Target vessel myocardial infarction (MI) (MI not clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Measured: 3 years
Stent Thrombosis (ARC Defined)
ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Measured: 0 to 1 day (Acute)
Stent Thrombosis (ARC Defined)
ARC defined: Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Measured: greater than 1 day to 30 days (Subacute)
Stent Thrombosis (ARC Defined)
Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Measured: 31 days - 393 days (Late)
Stent Thrombosis (ARC Defined)
Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Measured: >1 year (Very late)
Stent Thrombosis (ARC Defined)
Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Measured: 394 - 758 days (Very Late)
Stent Thrombosis (ARC Defined)
Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Measured: 394 - 1123 days (Very Late)
Stent Thrombosis (ARC Defined)
Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Measured: Overall (0 - 393 days)
Stent Thrombosis (ARC Defined)
Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Measured: Overall (0 - 758 days)
Stent Thrombosis (ARC Defined)
Stent Thrombosis as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344-2351). Result includes Definite/Probable/Possible.
Measured: Overall (0 - 1123 days)
Stent Thrombosis (Protocol Defined)
Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Measured: 0 to 1 day (Acute)
Stent Thrombosis (Protocol Defined)
Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Measured: > 1 day to 30 days (Subacute)
Stent Thrombosis (Protocol Defined)
Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Measured: 31 days to 393 days (Late)
Stent Thrombosis (Protocol Defined)
Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Measured: 31 - 758 days (Late)
Stent Thrombosis (Protocol Defined)
Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Measured: 31 - 1123 days (Late)
Stent Thrombosis (Protocol Defined)
Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Measured: Overall (0 - 393 days)
Stent Thrombosis (Protocol Defined)
Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Measured: Overall (0 - 758 days)
Stent Thrombosis (Protocol Defined)
Stent Thrombosis per protocol categorized as acute (≤1 day), subacute (>1 day and ≤30 days), and late (>30 days), and defined as clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis, or in absence of angiography, any unexplained death at any time or acute myocardial infarction* (ST segment elevation or new Q-wave) in the distribution of the target lesion within 30 days of the index procedure. (*Non-specific ST/T changes and cardiac enzymes do not suffice.). Result includes Definite/Probable/Possible.
Measured: Overall (0 - 1123 days)
All Death/ All MI/All Coronary Revascularization
This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.
Measured: 30 days
All Death/ All MI/All Coronary Revascularization
This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.
Measured: 240 days
All Death/ All MI/All Coronary Revascularization
This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.
Measured: 1 year
All Death/ All MI/All Coronary Revascularization
This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.
Measured: 2 years
All Death/ All MI/All Coronary Revascularization
This endpoint is a composite of all death, all myocardial infarction per protocol definition, and all revascularization.
Measured: 3 years
Cardiac Death/ All MI /CI-TLR
This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).
Measured: 30 days
Cardiac Death/ All MI /CI-TLR
This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).
Measured: 240 days
Cardiac Death/ All MI /CI-TLR
This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).
Measured: 1 year
Cardiac Death/ All MI /CI-TLR
This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).
Measured: 2 years
Cardiac Death/ All MI /CI-TLR
This endpoint is a composite of cardiac death, all myocardial infarction (MI)per protocol definition, and clinically-indicated target lesion revascularization (CI-TLR).
Measured: 3 years
Cardiac Death/MI
This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.
Measured: 30 days
Cardiac Death/MI
This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.
Measured: 240 days
Cardiac Death/MI
This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.
Measured: 1 year
Cardiac Death/MI
This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.
Measured: 2 years
Cardiac Death/MI
This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.
Measured: 3 years
All Coronary Revascularization (TVR and Non-TVR)
Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.
Measured: 30 days
All Coronary Revascularization (TVR and Non-TVR)
Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.
Measured: 240 days
All Coronary Revascularization (TVR and Non-TVR)
Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.
Measured: 1 year
All Coronary Revascularization (TVR and Non-TVR)
Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel.
Measured: 2 years
All Coronary Revascularization (TVR and Non-TVR)
Includes any revascularization intervention after the index procedure by any means (percutaneous or bypass surgery), including intervention to the target vessel, and intervention to a vessel other than the target vessel (per protocol).
Measured: 3 years
All TVR (CI and Non-CI)
Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.
Measured: 30 days
All TVR (CI and Non-CI)
Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.
Measured: 240 days
All TVR (CI and Non-CI)
Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.
Measured: 1 year
All TVR (CI and Non-CI)
Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure.
Measured: 2 years
All TVR (CI and Non-CI)
Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) in the target vessel from the index procedure (per protocol).
Measured: 3 years
All TLR (CI and Non-CI)
Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.
Measured: 30 days
All TLR (CI and Non-CI)
Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.
Measured: 240 days
All TLR (CI and Non-CI)
Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.
Measured: 1 year
All TLR (CI and Non-CI)
Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated.
Measured: 2 years
All TLR (CI and Non-CI)
Includes any repeat revascularization intervention after the index procedure by any means (percutaneous or bypass surgery) of the target lesion from the index procedure. This includes interventions classified as clinically indicated, and also includes interventions classified as not clinically indicated (per protocol).
Measured: 3 years
Clinically Indicated Target Vessel Revascularization (TVR)
Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Measured: 30 days
Clinically Indicated Target Vessel Revascularization
Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Measured: 240 days
Clinically Indicated Target Vessel Revascularization
Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Measured: 1 year
Clinically Indicated Target Vessel Revascularization
Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Measured: 2 years
Clinically Indicated Target Vessel Revascularization
Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery), of the target vessel. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).
Measured: 3 years
Clinically Indicated Target Lesion Revascularization (CI-TLR)
Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Measured: 30 days
Clinically Indicated Target Lesion Revascularization (CI-TLR)
Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Measured: 240 days
Clinically Indicated Target Lesion Revascularization (CI-TLR)
Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Measured: 1 year
Clinically Indicated Target Lesion Revascularization (CI-TLR)
Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms.
Measured: 2 years
Clinically Indicated Target Lesion Revascularization (CI-TLR)
Includes clinically indicated repeat revascularization after the index procedure by any means (percutaneous or bypass surgery) of the target lesion. Classification as clinically indicated is done prospectively and verified by angiographic core lab measurement, and requires ≥50% diameter stenosis with ischemic signs or symptoms (positive history of angina pectoris or objective signs of ischemia at rest (ECG changes) or during exercise test or abnormal invasive cardiac functional diagnostic test), or ≥70% diameter stenosis in the absence of the above-mentioned ischemic signs or symptoms (per protocol).
Measured: 3 years
Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)
Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Measured: 30 days
Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)
Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Measured: 240 days
Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)
Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Measured: 1 year
Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)
Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Measured: 2 years
Non Target Vessel MI (Q-wave, Non Q-wave)(Per Protocol)
Non target vessel myocardial infarction (MI) (MI clearly attributable to a non-target vessel), including Q-wave MI (new pathologic Q waves) and Non Q-wave MI (elevation of CK to ≥ two times the upper limit normal with elevated CK-MB in the absence of new pathological Q waves).
Measured: 3 years
Target Vessel MI - Q-wave and Non Q-wave (Per ARC)
ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Measured: 30 days
Target Vessel MI - Q-wave and Non Q-wave (Per ARC)
ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Measured: 240 days
Target Vessel MI - Q-wave and Non Q-wave (Per ARC)
ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Measured: 1 year
Target Vessel MI - Q-wave and Non Q-wave (Per ARC)
ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Measured: 2 years
Target Vessel MI - Q-wave and Non Q-wave (Per ARC)
ARC defined target vessel MI (MI not clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Measured: 3 years
Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)
ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Measured: 30 days
Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)
ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Measured: 240 days
Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)
ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Measured: 1 year
Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)
ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Measured: 2 years
Non Target Vessel MI- Q-wave, Non Q-wave (Per ARC)
ARC defined non-target vessel MI (MI clearly attributable to a non-target vessel): Myocardial Infarction as per Academic Research Consortium standardized definitions (Circulation 2007;115:2344- 2351).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2010
- Study completionDec 2013
Why it stopped: Study stopped at 3 years. Funding for trial withdrawn by sponsor.
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.
- Other trials for Coronary Artery 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marco A. Costa, MD, PhD, Principal investigator, Case Western University Hospital, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783796
- Sponsor's protocol ID
- 08-383
- Acronym
- SPIRIT SV
- Status last verified
- Apr 2019
- First submitted
- 30 Oct 2008
- Last updated
- 8 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spirit Small Vessel Registry (SPIRIT SV)
- ClinicalTrials.gov ID
- NCT00783796
- Acronym / sponsor ID
- SPIRIT SV / 08-383
- Keywords
- Coronary artery disease, Atherosclerosis, Myocardial ischemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped at 3 years. Funding for trial withdrawn by sponsor.
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Nov 2008 (estimated)
- Results
- Posted 5 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and effectiveness of the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions in small vessels, each in a different epicardial vessel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2.25mm XIENCE V® | Experimental | Device: 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent SystemPatients receiving the 2.25 mm XIENCE V® stent |
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 |
|---|---|---|
| 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent SystemTreatment of a maximum of two de novo native coronary artery lesions in small vessels. | Device | 2.25mm XIENCE V® |
Primary outcome
Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).
Time frame: 1 year
This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.
Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).
Time frame: 2 years
This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.
Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR).
Time frame: 3 years
This endpoint is a composite of cardiac death, target vessel myocardial infarction per protocol definition, and clinically-indicated target lesion revascularization.
96 secondary outcomes
Device Success (Per Lesion Basis, for Target Lesions Treated by 2.25 mm XIENCE V EECS With or Without Planned Overlap)
Time frame: From start of index procedure to end of index procedure
Procedural Success (Per Subject Basis, for ALL Target and Non-target Lesions)
Time frame: From the start of index procedure to end of index procedure
In-Stent Late Loss
Time frame: 240 days
In-segment Late Loss (LL)
Time frame: 240 Days
Proximal Late Loss
Time frame: 240 days
Distal Late Loss
Time frame: 240 days
In-stent % Diameter Stenosis
Time frame: 240 days
In-segment % Diameter Stenosis
Time frame: 240 days
Proximal % Diameter Stenosis
Time frame: 240 days
Distal % Diameter Stenosis
Time frame: 240 days
In-stent Angiographic Binary Restenosis (ABR) Rate
Time frame: 240 days
In-segment Angiographic Binary Restenosis (ABR) Rate
Time frame: 240 days
Proximal Angiographic Binary Restenosis (ABR) Rate
Time frame: 240 days
Distal Angiographic Binary Restenosis (ABR) Rate
Time frame: 240 days
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 30 days
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 240 days
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 1 year
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 2 years
All Death (Cardiac, Vascular, Non-cardiovascular)
Time frame: 3 years
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
Time frame: 30 days
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
Time frame: 240 days
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
Time frame: 1 year
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
Time frame: 2 years
Target Vessel MI - Q-wave and Non Q-wave (Per Protocol)
Time frame: 3 years
Stent Thrombosis (ARC Defined)
Time frame: 0 to 1 day (Acute)
Stent Thrombosis (ARC Defined)
Time frame: greater than 1 day to 30 days (Subacute)
Stent Thrombosis (ARC Defined)
Time frame: 31 days - 393 days (Late)
Stent Thrombosis (ARC Defined)
Time frame: >1 year (Very late)
Stent Thrombosis (ARC Defined)
Time frame: 394 - 758 days (Very Late)
Stent Thrombosis (ARC Defined)
Time frame: 394 - 1123 days (Very Late)
Stent Thrombosis (ARC Defined)
Time frame: Overall (0 - 393 days)
Stent Thrombosis (ARC Defined)
Time frame: Overall (0 - 758 days)
Stent Thrombosis (ARC Defined)
Time frame: Overall (0 - 1123 days)
Stent Thrombosis (Protocol Defined)
Time frame: 0 to 1 day (Acute)
Stent Thrombosis (Protocol Defined)
Time frame: > 1 day to 30 days (Subacute)
Stent Thrombosis (Protocol Defined)
Time frame: 31 days to 393 days (Late)
Stent Thrombosis (Protocol Defined)
Time frame: 31 - 758 days (Late)
Stent Thrombosis (Protocol Defined)
Time frame: 31 - 1123 days (Late)
Stent Thrombosis (Protocol Defined)
Time frame: Overall (0 - 393 days)
Stent Thrombosis (Protocol Defined)
Time frame: Overall (0 - 758 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marco A. Costa, MD, PhD principal investigator
Case Western University Hospital, Cleveland, OH
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System in people with Coronary Artery Disease and Atherosclerosis, run by Abbott Medical Devices at 34 sites in United States.
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: stopped early, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. 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 5 Jan 2012). 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?
Composite Rate of Cardiac Death, Target Vessel Myocardial Infarction (MI) (Per Protocol Definition) & Clinically Indicated Target Lesion Revascularization (CI-TLR). (time frame: 1 year). 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?
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 8 May 2019.