SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System

October 8, 2012 updated by: Abbott Medical Devices

SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®). The XIENCE V® arm will be compared to an active control, represented by the FDA-approved TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent System (TAXUS®), commercially available from Boston Scientific.

TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is manufactured by Boston Scientific.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The completion of the SPIRIT IV clinical trial at three years is justified by the consistent long-term clinical evidence supporting the safety and efficacy of the XIENCE V EECSS in complex, real-world patients across multiple geographies. As SPIRIT IV was designed as a continued access trial, completing the clinical follow-up at the three-year visit does not conflict with any FDA requirements. Abbott Vascular is committed to providing clinical outcomes through three years. The clinical evidence provided from across multiple geographies, in complex populations thus supports Abbott Vascular's proposal to complete the SPIRIT IV RCT at the three-year clinical follow-up.

The SPIRIT IV Clinical Trial is a randomized, active-controlled, single-blinded, multicenter clinical trial in the US that will enroll approximately 3,690 subjects (2:1 randomization XIENCE V®: TAXUS®). The trial allows the treatment of up to three de novo native coronary artery lesions, maximum of two lesion per epicardial vessel, with reference vessel diameters (RVD) ≥ 2.5 mm to ≤ 4.25 mm and lesion lengths ≤ 28 mm. (NOTE: RVD ≥ 2.5 mm to ≤ 3.75 mm until 4.0 mm TAXUS® is commercially available). All subjects will be screened per the protocol inclusion and exclusion criteria and enrolled subjects will have clinical follow-up at 30, 180, and 270 days and 1, 2, and 3 years.

Study Type

Interventional

Enrollment (Actual)

3687

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Scottsdale Healthcare
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Heart Hospital
    • California
      • Fairfax, California, United States, 22031
        • Inova Fairfax Hospital
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital
      • La Jolla, California, United States, 92037
        • San Diego Cardiovascular Associates
      • Los Angeles, California, United States, 90017
        • Good Samaritan Hospital - LA
      • Sacramento, California, United States, 95819
        • Mercy General Hospital
      • Santa Rosa, California, United States, 95404-1797
        • Sutter Medical Center of Santa Rosa
    • Colorado
      • Aurora, Colorado, United States, 80012
        • The Medical Center of Aurora
      • Fort Collins, Colorado, United States, 80528
        • Poudre Valley Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Pensacola, Florida, United States, 32504-8721
        • Sacred Heart Hospital
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • The Heart Center of Indiana
      • Indianapolis, Indiana, United States, 46237
        • St. Francis Hospital and Health Centers
    • Iowa
      • Des Moines, Iowa, United States, 50266
        • Iowa Heart Center P.C.
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Central Baptist Hospital
      • Louisville, Kentucky, United States, 40202
        • Jewish Hospital
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
      • Baltimore, Maryland, United States, 21218
        • Union Memorial Hospital
      • Takoma Park, Maryland, United States, 20912
        • Washington Adventist Hospital
      • Towson, Maryland, United States, 21204
        • St. Joseph Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Worcester, Massachusetts, United States, 01655
        • UMASS Memorial Medical Center
      • Worcester, Massachusetts, United States, 01608
        • Saint Vincent Hospital
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Bay Regional Medical Center
      • Dearborn, Michigan, United States, 48124
        • Oakwood Hospital and Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Hospital
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Medical Center
      • Lansing, Michigan, United States, 48910
        • Ingham Regional Medical Center
      • Petoskey, Michigan, United States, 49770
        • Northern Michigan Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
    • Montana
      • Missoula, Montana, United States, 59802
        • St. Patrick Hospital
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchock Medical Center
    • New York
      • Buffalo, New York, United States, 14209
        • Millard Fillmore Hospital
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York City, New York, United States, 10021
        • New York Presbyterian Hospital-Cornell
      • Pomona, New York, United States, 10970
        • The Valley Hospital
      • Stony Brook, New York, United States, 11794
        • Stony Brook Hospital and Medical Center
      • Syracuse, New York, United States, 13203
        • St. Joseph's Hospital Health Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28233
        • Presbyterian Hospital - Charlotte
      • Greenville, North Carolina, United States, 27834
        • Pitt County Memorial Hospital
      • Raleigh, North Carolina, United States, 27610
        • Wake Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Elyria, Ohio, United States, 44035
        • EMH Regional Medical Center
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
      • Columbia, South Carolina, United States, 29204
        • Sisters of Charity Providence Hospitals
      • Greenville, South Carolina, United States, 29605
        • St. Francis Health System
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Vanderbilt Vniversity Medical Center
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Plaza Medical Center of Fort Worth
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • St. Luke's Medical Center - Milwaukee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Subject must be at least 18 years of age
  • Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving XIENCE V® and he/she or his/her legally authorized representative provides 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 to undergo all protocol-required follow-up procedures
  • Subject must agree not to participate in any other clinical study for a period of one year following the index procedure

Angiographic Inclusion Criteria:

  • Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and treatment of up to a three de novo target lesions, maximum of two de novo target lesions per epicardical vessel. (NOTE: RVD ≥2.5 mm to ≤3.75 mm until 4.0 mm TAXUS® is commercially available)
  • Target lesion(s) must measure ≤28 mm in length by visual estimation(≥3 mm of non-diseased tissue on either side of the target lesion should be covered by the study stent)
  • If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria
  • If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria
  • The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1
  • Non-study, percutaneous intervention for lesions in a target vessel (including side branches) is allowed if done ≥ 9 months prior to the index procedure
  • Non-study percutaneous intervention for lesions in a non-target vessel involving:
  • Successful and uncomplicated (visually estimated diameter stenosis < 50%, TIMI Grade 3 flow, no ECG changes, prolonged chest pain, or angiographic complications) bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 24 hours prior to the index procedure or during (before randomization) the index procedure. For interventions done within 24 to 48 hours prior to the index procedure, CK and CK-MB must be assessed to be < 2 times the upper limit of normal at the time of the index procedure. NOTE: Procedures within the 24 hour period preceding the index procedure are not permitted
  • Unsuccessful or complicated bare-metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if done ≥ 30 days prior to the index procedure
  • Drug-eluting stent treatment is allowed if done ≥ 90 days prior to the index procedure
  • Non-study, percutaneous interventions for lesion(s) in a target vessel (including side branches) or non-target vessel are allowed if done ≥ 9 months after the index procedure

General Exclusion Criteria:

  • Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned within normal limits at the time of procedure
  • The subject is currently experiencing clinical symptoms consistent with AMI
  • Subject has current unstable arrhythmias
  • Subject has a known left ventricular ejection fraction (LVEF) < 30%
  • Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
  • Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days prior to or after the procedure
  • Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.)
  • Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
  • Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated
  • Elective surgery that will require discontinuing either aspirin or clopidogrel is planned within the first 9 months after the procedure
  • Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
  • Subject has known renal insufficiency (e.g., serum creatinine level of > 2.5 mg/dL or subject on dialysis)
  • Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
  • Subject has had a significant GI or 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 life expectancy of less than one year
  • Subject is already participating in another clinical study that has not yet reached 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 and effective contraception must be used up to 1 year following the index procedure)
  • Angiographic Exclusion Criteria
  • The target lesion(s) meets any of the following criteria:
  • Left main coronary artery location including left main ostial location (NOTE: RCA-aorto-ostial lesions are not excluded)
  • Located within 2 mm of the origin of the LAD or LCX
  • Located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and any visually estimated diameter stenosis > 20%) arterial or saphenous vein graft
  • Involves a bifurcation in which the side branch is ≥ 2 mm in diameter AND the ostium of the side branch is > 50% stenosed by visual estimation
  • Involves a side branch requiring pre-dilatation
  • Total occlusion (TIMI flow 0) prior to wire crossing
  • Excessive tortuosity proximal to or within the lesion
  • Extreme angulation (≥ 90º) proximal to or within the lesion
  • Heavy calcification
  • Restenotic from previous intervention
  • Subject has received brachytherapy in any epicardial vessel (including side branches)
  • The target vessel contains thrombus
  • Another clinically significant lesion in the target vessel is present that requires or has a high probability of requiring PCI during the index procedure
  • Another lesion in a target or non-target vessel (including all side branches) is present that requires or has a high probability of requiring PCI within 9 months after the index procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XIENCE V®
Device: XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Other Names:
  • XIENCE V® Everolimus Eluting Coronary Stent System
Active Comparator: TAXUS™ EXPRESS2™
Device: TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Other Names:
  • TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemia Driven Target Lesion Failure (TLF)
Time Frame: 1 year
Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Cause Mortality
Time Frame: 1 year
1 year
All Cause Mortality
Time Frame: 180 days
180 days
All Cause Mortality
Time Frame: 30 days
30 days
Ischemia Driven Target Vessel Failure (TVF)
Time Frame: 30 days
Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
30 days
Ischemia Driven Target Vessel Failure (TVF)
Time Frame: 180 days
Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
180 days
Ischemia Driven Target Vessel Failure (TVF)
Time Frame: 270 days
Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
270 days
Ischemia Driven Target Vessel Failure (TVF)
Time Frame: 1 year
Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
1 year
Ischemia Driven Target Vessel Failure (TVF)
Time Frame: 2 years
Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
2 years
Ischemia Driven Target Vessel Failure (TVF)
Time Frame: 3 years
Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
3 years
Ischemia Driven Target Lesion Revascularization (TLR)
Time Frame: 30 days

Revascularization of a target lesion associated with any of the following:

  • positive functional ischemia study
  • ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
  • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
30 days
Ischemia Driven Target Lesion Revascularization (TLR)
Time Frame: 180 days

Revascularization of a target lesion associated with any of the following:

  • positive functional ischemia study
  • ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
  • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
180 days
Ischemia Driven Target Lesion Revascularization (TLR)
Time Frame: 270 days

Revascularization of a target lesion associated with any of the following:

  • positive functional ischemia study
  • ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
  • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
270 days
Ischemia Driven Target Lesion Revascularization (TLR)
Time Frame: 1 year

Revascularization of a target lesion associated with any of the following:

  • positive functional ischemia study
  • ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
  • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
1 year
Ischemia Driven Target Lesion Revascularization (TLR)
Time Frame: 2 years

Revascularization of a target lesion associated with any of the following:

  • positive functional ischemia study
  • ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
  • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
2 years
Ischemia Driven Target Lesion Revascularization (TLR)
Time Frame: 3 years

Revascularization of a target lesion associated with any of the following:

  • positive functional ischemia study
  • ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
  • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
3 years
Ischemia Driven Target Vessel Revascularization (TVR)
Time Frame: 30 days

Revascularization of a lesion within the target vessel associated with any of the following:

  • positive functional ischemia study
  • ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
  • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
30 days
Ischemia Driven Target Vessel Revascularization (TVR)
Time Frame: 180 days

Revascularization of a lesion within the target vessel associated with any of the following:

  • positive functional ischemia study
  • ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
  • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
180 days
Ischemia Driven Target Vessel Revascularization (TVR)
Time Frame: 270 days

Revascularization of a lesion within the target vessel associated with any of the following:

  • positive functional ischemia study
  • ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
  • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
270 days
Ischemia Driven Target Vessel Revascularization (TVR)
Time Frame: 1 year

Revascularization of a lesion within the target vessel associated with any of the following:

  • positive functional ischemia study
  • ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
  • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
1 year
Ischemia Driven Target Vessel Revascularization (TVR)
Time Frame: 2 years

Revascularization of a lesion within the target vessel associated with any of the following:

  • positive functional ischemia study
  • ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
  • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
2 years
Ischemia Driven Target Vessel Revascularization (TVR)
Time Frame: 3 years

Revascularization of a lesion within the target vessel associated with any of the following:

  • positive functional ischemia study
  • ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA)
  • angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
3 years
Ischemia Driven Major Adverse Cardiac Events (MACE)
Time Frame: 30 days
Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
30 days
Ischemia Driven Major Adverse Cardiac Events (MACE)
Time Frame: 180 days
Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
180 days
Ischemia Driven Major Adverse Cardiac Events (MACE)
Time Frame: 270 days
Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
270 days
Ischemia Driven Major Adverse Cardiac Events (MACE)
Time Frame: 1 years
Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
1 years
Ischemia Driven Major Adverse Cardiac Events (MACE)
Time Frame: 2 years
Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
2 years
Ischemia Driven Major Adverse Cardiac Events (MACE)
Time Frame: 3 years
Patients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
3 years
Acute Success (Clinical Device)
Time Frame: Acute: At time of index procedure
Successful delivery and deployment of the first implanted study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stents) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Bailout subjects will be included as device success only if the above criteria for clinical device are met.
Acute: At time of index procedure
Acute Success (Clinical Procedure)
Time Frame: Acute: At time of index procedure
Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days following the index procedure. In multiple lesion setting all lesions must meet clinical procedure success.
Acute: At time of index procedure
All Myocardial Infarction (MI)
Time Frame: 30 days
30 days
All MI
Time Frame: 180 days
180 days
All MI
Time Frame: 270 days
270 days
All MI
Time Frame: 1 year
1 year
All MI
Time Frame: 2 years
2 years
All MI
Time Frame: 3 years
3 years
All Cause Mortality
Time Frame: 270 days
270 days
All Cause Mortality
Time Frame: 2 years
2 years
All Cause Mortality
Time Frame: 3 years
3 years
Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
Time Frame: 30 days
30 days
Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
Time Frame: 180 days
180 days
Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
Time Frame: 270 days
270 days
Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
Time Frame: 1 year
1 year
Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
Time Frame: 2 years
2 years
Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
Time Frame: 3 years
3 years
Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition
Time Frame: 0-30 days

ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post

* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.

† Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.
0-30 days
Definite + Probable Stent Thrombosis Rate Based on ARC Definition
Time Frame: 31-393 days

ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post

* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.

† Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.
31-393 days
Definite + Probable Stent Thrombosis Rate Based on ARC Definition
Time Frame: 0 -393 days

ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post

* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.

† Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.
0 -393 days
Definite + Probable Stent Thrombosis Rate Based on ARC Definition
Time Frame: 0-758 days

ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post

* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.

† Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.
0-758 days
Definite + Probable Stent Thrombosis Rate Based on ARC Definition
Time Frame: 0-1123 days

ARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute*: 0-24 hours post implantation Subacute*: >24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: >1 year post

* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community.

† Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.
0-1123 days
Protocol Defined Stent Thrombosis Rate
Time Frame: 0-30 days

ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:

  • Clinical presentation of acute coronary syndrome with angiographic evidence of ST
  • In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
0-30 days
Protocol Defined Stent Thrombosis Rate
Time Frame: 31-393 days

ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:

  • Clinical presentation of acute coronary syndrome with angiographic evidence of ST
  • In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
31-393 days
Protocol Defined Stent Thrombosis Rate
Time Frame: 0-393 days

ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:

  • Clinical presentation of acute coronary syndrome with angiographic evidence of ST
  • In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
0-393 days
Protocol Defined Stent Thrombosis Rate
Time Frame: 0-758 days

ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:

  • Clinical presentation of acute coronary syndrome with angiographic evidence of ST
  • In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
0-758 days
Protocol Defined Stent Thrombosis Rate
Time Frame: 0-1123 days

ST will be categorized as acute (≤ 1day), subacute (>1 day to ≤ 30 days) and late (>30 days) and will be defined as any of the following:

  • Clinical presentation of acute coronary syndrome with angiographic evidence of ST
  • In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)* in the distribution of the target lesion within 30 days *(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
0-1123 days
Cardiac Death or Target Vessel MI Rate
Time Frame: 30 days
30 days
Cardiac Death or Target Vessel MI Rate
Time Frame: 180 days
180 days
Cardiac Death or Target Vessel MI Rate
Time Frame: 270 days
270 days
Cardiac Death or Target Vessel MI Rate
Time Frame: 1 year
1 year
Cardiac Death or Target Vessel MI Rate
Time Frame: 2 years
2 years
Cardiac Death or Target Vessel MI Rate
Time Frame: 3 years
3 years
Ischemia Driven Target Lesion Failure (TLF)
Time Frame: 30 days
Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
30 days
Ischemia Driven Target Lesion Failure (TLF)
Time Frame: 180 days
Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
180 days
Ischemia Driven Target Lesion Failure (TLF)
Time Frame: 270 days
Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
270 days
Ischemia Driven Target Lesion Failure (TLF)
Time Frame: 2 years
Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
2 years
Ischemia Driven Target Lesion Failure (TLF)
Time Frame: 3 years
Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Gregg W Stone, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 23, 2006

First Submitted That Met QC Criteria

March 23, 2006

First Posted (Estimate)

March 27, 2006

Study Record Updates

Last Update Posted (Estimate)

November 7, 2012

Last Update Submitted That Met QC Criteria

October 8, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-368

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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