SPIRIT Small Vessel Registry (SPIRIT SV)

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.

Study Overview

• Status: Terminated
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Atherosclerosis
• Intervention / Treatment: Device: 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Scottsdale Healthcare
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Clearwater, Florida, United States, 33756
      • Morton Plant Hospital
    • Pensacola, Florida, United States, 32504-8721
      • Sacred Heart Hospital
  • Illinois
    • Rockford, Illinois, United States, 61107
      • St. Anthony Hospital
    • Springfield, Illinois, United States, 62769
      • St. John's Hospital / Prairie Education & Research Cooperative
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
    • Baltimore, Maryland, United States, 21218
      • Union Memorial Hospital
    • Towson, Maryland, United States, 21204
      • St. Joseph Medical Center
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Petoskey, Michigan, United States, 49770
      • Northern Michigan Hospital
    • Ypsilanti, Michigan, United States, 48197
      • St. Joseph Mercy Hospital
  • Minnesota
    • Saint Cloud, Minnesota, United States, 56303
      • St. Cloud Hospital
  • Montana
    • Missoula, Montana, United States, 59802
      • St. Patrick Hospital
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper Health System
  • New York
    • New York, New York, United States, 10011
      • Gotham Cardiovascular Reasearch, PC. (St. Vincent's Medical Center-closing, pts moved)
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Charlotte, North Carolina, United States, 28204
      • Presbyterian Hospital
    • Raleigh, North Carolina, United States, 27610
      • WakeMed Hospital
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Elyria, Ohio, United States, 44035
      • EMH Regional Medical Center
    • Toledo, Ohio, United States, 43608
      • St. Vincent Mercy Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Hillcrest Medical Center
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford USD Medical Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37934
      • Baptist West Hospital
  • Texas
    • Amarillo, Texas, United States, 79106
      • Northwest Texas Healthcare System
    • Tyler, Texas, United States, 75701
      • Mother Frances Hospital
  • Washington
    • Bellevue, Washington, United States, 98004
      • Overlake Hospital Medical Center
    • Bellingham, Washington, United States, 98225
      • St. Joseph Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

General Inclusion Criteria

1. Subject must be at least 18 years of age.
2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedure.
3. 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).
4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
5. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria

1. One target or two (two target or one target and one non-target) de novo lesion(s), each in a different epicardial vessel.
2. If there are two target lesions or one target and one non-target lesion, both lesions must satisfy the angiographic eligibility criteria.
3. 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.

4. 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.

5. 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

1. 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.
2. The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
3. Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.
4. 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).
5. Subject has received coronary brachytherapy in any epicardial vessel.
6. Subject has received any organ transplant or is on a waiting list for any organ transplant.
7. Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
8. Subject is receiving or scheduled to receive planned radiation therapy to the chest or mediastinum.
9. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).
10. Subject is receiving chronic anticoagulation therapy (e.g., heparin, coumadin).
11. Subjects who will require Low Molecular Weight Heparin (LMWH) post-procedure.
12. 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.
13. Elective surgery is planned within 12 months after the procedure that will require discontinuing either aspirin or clopidogrel.
14. 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).
15. Subject has known renal insufficiency (eg, serum creatinine level ≥ 2.5 mg/dL, or on dialysis).
16. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
17. Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
18. Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.
19. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
20. 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).
21. Subject is currently participating in another clinical study that has not yet completed its primary endpoint.
22. 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

1. 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.
2. 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.
3. Total occlusion (TIMI flow 0), prior to crossing with the wire.
4. Another lesion requiring revascularization is located in the same epicardial vessel of either the target or non-target lesion.
5. Restenotic lesion.
6. Aorto-ostial lesion (within 3 mm of the aorta junction).
7. Left main location.
8. Lesion located within 2 mm of the origin of the LAD (left anterior descending) or LCX (left coronary artery)
9. Extreme angulation (≥90°) or excessive tortuosity (≥ two 45° angles) proximal to or within the target or non-target lesion.
10. Heavy calcification proximal to or within the target or non-target lesion(s).
11. Target or non-target vessel contains thrombus as indicated in the angiographic images.
12. 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).
13. 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.
14. 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.
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2.25mm XIENCE V®; Patients receiving the 2.25 mm XIENCE V® stent	Device: 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System; Treatment of a maximum of two de novo native coronary artery lesions in small vessels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	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.	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.	240 days
In-segment Late Loss (LL)	In-segment minimum lumen diameter (MLD) post-procedure minus in-segment MLD at angiographic follow-up.	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).	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).	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.	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.	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.	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.	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.	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.	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.	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.	240 days
All Death (Cardiac, Vascular, Non-cardiovascular)	All death, including death from cardiac, vascular, and non-cardiovascular causes.	30 days
All Death (Cardiac, Vascular, Non-cardiovascular)	All death, including death from cardiac, vascular, and non-cardiovascular causes.	240 days
All Death (Cardiac, Vascular, Non-cardiovascular)	All death, including death from cardiac, vascular, and non-cardiovascular causes.	1 year
All Death (Cardiac, Vascular, Non-cardiovascular)	All death, including death from cardiac, vascular, and non-cardiovascular causes.	2 years
All Death (Cardiac, Vascular, Non-cardiovascular)	All death, including death from cardiac, vascular, and non-cardiovascular causes (per protocol).	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).	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).	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).	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).	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).	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.	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.	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.	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.	>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.	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.	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.	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.	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.	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.	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.	> 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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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).	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).	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).	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).	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).	3 years
Cardiac Death/MI	This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.	30 days
Cardiac Death/MI	This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.	240 days
Cardiac Death/MI	This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.	1 year
Cardiac Death/MI	This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.	2 years
Cardiac Death/MI	This endpoint is a composite of cardiac death and all myocardial infarction per protocol definition.	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.	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.	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.	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.	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).	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.	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.	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.	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.	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).	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.	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.	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.	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.	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).	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.	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.	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.	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.	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).	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.	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.	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.	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.	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	3 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Marco A. Costa, MD, PhD, Case Western University Hospital, Cleveland, OH

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: October 30, 2008
• First Submitted That Met QC Criteria: October 30, 2008
• First Posted (Estimate): November 2, 2008

Study Record Updates

• Last Update Posted (Actual): May 8, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Coronary artery disease; Atherosclerosis; Myocardial ischemia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia; Atherosclerosis; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: 08-383