SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

November 16, 2011 updated by: Abbott Medical Devices

SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects With de Novo Native Coronary Artery Lesions

This study is divided into 5 arms:

  1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter stents) to the Food and Drug Administration (FDA) approved commercially available active control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System
  2. US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS
  3. US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS
  4. US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS
  5. Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0 mm diameter stents) in Japan

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the SPIRIT III clinical trial is to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS). The XIENCE V® EECS (XIENCE V® arm) will be compared to an active control group represented by the FDA approved commercially available Boston Scientific TAXUS® EXPRESS2™ Paclitaxel-Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System (TAXUS® arm).

The SPIRIT III clinical trial consists of a randomized clinical trial (RCT) in the US which will enroll approximately 1,002 subjects (2:1 randomization XIENCE V® EECS : TAXUS® EXPRESS2™ PECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes >= 2.5 mm and <= 3.75 mm.

The SPIRIT III clinical trial also consists of three concurrent US non-randomized arms (2.25 mm diameter stent, 4.0 mm diameter stent and 38 mm length stent arms) and one Japanese non-randomized arm as follows:

  1. 105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 2.25 mm and < 2.5 mm and lesion length <= 22 mm will be enrolled concurrently in the US 2.25 mm non-randomized treatment arm
  2. 80 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 3.75 mm and >= 4.25 mm and lesion length <= 28 mm will be enrolled concurrently in the US 4.0 mm non-randomized treatment arm
  3. 105 subjects with a maximum of two de novo native coronary artery lesion within vessel sizes > 3.0 mm and < 4.25 mm and lesion length > 24 mm and < 32 mm will be enrolled concurrently in the US 38 mm non-randomized treatment arm.
  4. 88 Japanese subjects with a maximum of two de novo native coronary artery lesions within vessel sizes >= 2.5 mm and <= 4.25 mm and lesion length <= 28 mm will be enrolled concurrently in the non-randomized Japanese arm.

All subjects in the RCT and the four non-randomized arms will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the TAXUS® arm of US RCT.

Subjects enrolled in the US RCT will be sub-grouped based on whether they will have an angiographic and/or an intravascular ultrasound (IVUS) follow-up at 240 days as follows:

Group A: Angiographic and IVUS follow-up at 240 days (N=240) Group B: Angiographic follow-up at 240 days (N=324) Group C: No angiographic or IVUS follow-up (N=438)

All subjects will have clinical follow-up at 30, 180, 240 and 270 days (Data collected through 270 days will be submitted as the primary data set for US and Japanese market approval), and 1, 2, 3, 4, and 5 years (for annual reports).

All subjects enrolled into three US non-randomized arms (N=105 for 2.25 mm arm, N=80 for 4.0 mm arm and N=105 for 38 mm stent arm) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic follow-up at 240 days. No IVUS follow-up is required for subjects enrolled in these arms.

All subjects enrolled into the Japanese non-randomized arm (N=88) will have clinical follow-up at 30, 180, 240, and 270 days, and angiographic and IVUS follow-up at 240 days.

All subjects who receive a bailout stent will be assigned to Group A follow-up subgroup (angiographic and IVUS follow-up at 240 days after the index procedure), regardless of their primary assignment at randomization. At sites without IVUS capability, subjects receiving bailout stent will be assigned to Group B follow-up subgroup (angiographic follow-up at 240 days after the index procedure). Angiographic follow-up is required for all bailout subjects at 240 days.

Data from the US RCT will be submitted to the FDA as the primary data set for product approval for RVD >= 2.5 mm and <= 3.75 mm (2.5 mm, 3.0 mm and 3.5 mm stents). Combined data of the US trial/Japanese non-randomized arm will be submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) for Japanese approval for RVD>=2.5 mm and <= 4.25 mm (2.5 mm, 3.0 mm 3.5 mm and 4.0 mm stents). Data from the Japanese non-randomized arm will be submitted to the FDA as additional safety data. Data from the US non-randomized arms of the trial will be the primary data sets for approval for 2.25 mm diameter stent (RVD > 2.25 mm and < 2.5 mm), 4.0 mm diameter stent (RVD > 3.75 mm and <= 4.25 mm) and 38 mm length stent (RVD > 3.0 mm and <= 4.25 mm and lesion length > 24 mm and <= 32 mm), respectively in the US.

A pharmacokinetic substudy will be carried out in a minimum of 5 pre-determined sites in the US and a minimum of 5 pre-determined sites in Japan. In the US, the pharmacokinetics (PK) of everolimus, as delivered by the XIENCE V® EECS will be analyzed in a subset of 15 subjects (minimum) with single vessel/lesion treatment, and up to 20 subjects with dual vessel/lesion treatment, respectively. In Japan, a minimum of 10 subjects with single vessel/lesion treatment and up to 20 subjects with dual vessel/lesion treatment will have a PK measurements performed. These subsets will include subjects receiving overlapping stents.

Study Type

Interventional

Enrollment (Actual)

1002

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
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Baptist Medical Center Princeton
      • Birmingham, Alabama, United States, 35213
        • Baptist Health System - Montclair
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Heart Hospital
    • California
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital
      • Los Angeles, California, United States, 87106
        • Good Samaritan Hospital
      • Oakland, California, United States, 94609
        • Alta Bates Summit Medical Center
      • Sacramento, California, United States, 95819
        • Mercy General Hospital
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Poudre Valley Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Medical Center (prev. North Ridge MC)
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States, 30342
        • Saint Joseph's Hospital of Atlanta
      • Atlanta, Georgia, United States, 30308
        • Emory Crawford Long Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Elmhurst, Illinois, United States, 60148
        • Elmhurst Memorial Hospital
      • Springfield, Illinois, United States, 62701
        • St. John's Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • The Heart Center of IN, LLC
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Jewish Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
      • Takoma Park, Maryland, United States, 20912
        • Washington Adventist Hospital
      • Towson, Maryland, United States, 21204
        • St. Joseph Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
    • Michigan
      • Detroit, Michigan, United States, 48236
        • St John Hospital & Medical Center
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Hospital
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Medical Center
      • Petoskey, Michigan, United States, 49770
        • Northern Michigan Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital
      • St. Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital
    • 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-Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack Medical Center
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 28204
        • Presbyterian Hospital
    • New York
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • Syracuse, New York, United States, 13203
        • St. Joseph's Hospital Health Center
    • North Carolina
      • Charlotte, North Carolina, United States, 87106
        • Presbyterian Hospital
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Raleigh, North Carolina, United States, 27610
        • Wake Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist 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
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • The University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, United States, 73112
        • Integris Baptist Medical, Inc.
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Sacred Heart Medical Center
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17043
        • Pinnacle Health @ Harrisburg Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General 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, 29403
        • Medical University of South Carolina
    • Texas
      • Austin, Texas, United States, 78756
        • Heart Hospital of Austin
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
      • Houston, Texas, United States, 77030
        • Methodist Hospital
      • San Antonio, Texas, United States, 78215
        • TexSAn Heart Hospital
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • St. Luke's Medical Center

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

Inclusion Criteria:

  • Target lesion(s) must be located in a native epicardial vessel with visually estimated diameter between >= 2.25 mm and <= 4.25 mm and a lesion length <= 32 mm
  • The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of >= 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of >= 1
  • Non-study, percutaneous intervention for lesions in a non-target vessel is allowed if done >= 90 days prior to the index procedure (subjects who received brachytherapy will be excluded from the trial)

Exclusion Criteria:

  • 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
  • Lesion involving a bifurcation >= 2 mm in diameter or ostial lesion > 50% stenosed by visual estimation or side branch requiring predilatation
  • Located in a major epicardial vessel that has been previously treated with brachytherapy
  • Located in a major epicardial vessel that has been previously treated with percutaneous intervention < 9 months prior to index procedure
  • Total occlusion (TIMI flow 0), prior to wire passing
  • The target vessel contains thrombus
  • Another significant lesion (> 40% diameter stenosis [DS]) is located in the same epicardial vessel as the target lesion

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: 1
XIENCE V® Everolimus Eluting Coronary Stent System
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: 2
TAXUS® EXPRESS2™Paclitaxel Eluting Coronary Stent System
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
Primary Endpoint: In-segment Late Loss (LL)
Time Frame: 240 days
In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at 240 day follow-up and 5 mm proximal and 5mm distal to the stent equals Late Loss. MLD defined: The average of two orthogonal views (when possible) of the narrowest point within the area of assessment.
240 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Secondary Endpoint: Ischemia Driven Target Vessel Failure (ID-TVF)
Time Frame: 270 days

The composite endpoint comprised of:

  • Cardiac death (death in which a cardiac cause cannot be excluded)
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
  • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
270 days
Target Vessel Failure (TVF)
Time Frame: 30 days

The composite endpoint comprised of:

  • Cardiac death (death in which a cardiac cause cannot be excluded)
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
  • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
30 days
Target Vessel Failure (TVF)
Time Frame: 180 days

The composite endpoint comprised of:

  • Cardiac death (death in which a cardiac cause cannot be excluded)
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
  • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
180 days
Target Vessel Failure (TVF)
Time Frame: 1 year

The composite endpoint comprised of:

  • Cardiac death (death in which a cardiac cause cannot be excluded)
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
  • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
1 year
Target Vessel Failure (TVF)
Time Frame: 2 year

The composite endpoint comprised of:

  • Cardiac death (death in which a cardiac cause cannot be excluded)
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
  • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
2 year
Target Vessel Failure (TVF)
Time Frame: 3 year

The composite endpoint comprised of:

  • Cardiac death (death in which a cardiac cause cannot be excluded)
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
  • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
3 year
Target Vessel Failure (TVF)
Time Frame: 4 year

The composite endpoint comprised of:

  • Cardiac death (death in which a cardiac cause cannot be excluded)
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
  • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
4 year
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time Frame: 30 days

Revascularization @ target lesion associated w/ any of following:

(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
30 days
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time Frame: 180 days

Revascularization @ target lesion associated w/ any of following:

(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
180 days
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time Frame: 270 days

Revascularization @ target lesion associated w/ any of following:

(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
270 days
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time Frame: 1 years

Revascularization @ target lesion associated w/ any of following:

(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
1 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time Frame: 2 years

Revascularization @ target lesion associated w/ any of following:

(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
2 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time Frame: 3 year

Revascularization @ target lesion associated w/ any of following:

(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
3 year
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time Frame: 4 year

Revascularization @ target lesion associated w/ any of following:

(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
4 year
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time Frame: 30 days

Revascularization at the target vessel associated with any of the following

  • Positive functional ischemia study
  • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
  • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events
30 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time Frame: 180 days

Revascularization at the target vessel associated with any of the following

  • Positive functional ischemia study
  • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
  • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events
180 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time Frame: 270 days

Revascularization at the target vessel associated with any of the following

  • Positive functional ischemia study
  • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
  • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events
270 days
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time Frame: 1 year

Revascularization at the target vessel associated with any of the following

  • Positive functional ischemia study
  • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
  • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events
1 year
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time Frame: 2 years

Revascularization at the target vessel associated with any of the following

  • Positive functional ischemia study
  • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
  • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events
2 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time Frame: 3 years

Revascularization at the target vessel associated with any of the following

  • Positive functional ischemia study
  • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
  • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events
3 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time Frame: 4 years

Revascularization at the target vessel associated with any of the following

  • Positive functional ischemia study
  • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
  • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events
4 years
Ischemia Driven Major Adverse Cardiac Event (MACE)
Time Frame: 30 days

The composite endpoint comprised of:

  • Cardiac death
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
30 days
Ischemia Driven Major Adverse Cardiac Event (MACE)
Time Frame: 180 days

The composite endpoint comprised of:

  • Cardiac death
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
180 days
Ischemia Driven Major Adverse Cardiac Event (MACE)
Time Frame: 270 days

The composite endpoint comprised of:

  • Cardiac death
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
270 days
Ischemia Driven Major Adverse Cardiac Event (MACE)
Time Frame: 1 year

The composite endpoint comprised of:

  • Cardiac death
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
1 year
Ischemia Driven Major Adverse Cardiac Event(MACE)
Time Frame: 2 years

The composite endpoint comprised of:

  • Cardiac death
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
2 years
Ischemia Driven Major Adverse Cardiac Event (MACE)
Time Frame: 3 year

The composite endpoint comprised of:

  • Cardiac death
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
3 year
Ischemia Driven Major Adverse Cardiac Event (MACE)
Time Frame: 4 year

The composite endpoint comprised of:

  • Cardiac death
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
4 year
In-stent % Angiographic Binary Restenosis (% ABR) Rate
Time Frame: at 240 days
Percent of subjects with a follow-up in-stent percent diameter stenosis of ≥ 50% per quantitative coronary angiography (QCA)
at 240 days
In-segment % Angiographic Binary Restenosis (% ABR) Rate
Time Frame: 240 days
Percent of subjects with a follow-up in-segment percent diameter stenosis of ≥ 50% per QCA
240 days
Persisting Incomplete Stent Apposition, Late-acquired Incomplete Stent Apposition, Aneurysm, Thrombosis, and Persisting Dissection
Time Frame: at 240 days

Incomplete Apposition (Persisting & Late acquired): Failure to completely appose vessel wall w/ ≥1 strut separated from vessel wall w/ blood behind strut per ultrasound. Aneurysm: Abnormal vessel expansion ≥ 1.5 of reference vessel diameter. Thrombus: Protocol & ARC definition.

Persisting dissection @ follow-up, present post-procedure.
at 240 days
Acute Success: Clinical Device
Time Frame: In-hospital
Successful delivery and deployment of 1st implanted study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.
In-hospital
Acute Success: Clinical Procedure
Time Frame: In-hospital
Successful delivery and deployment of study stent/s @ the intended target lesion and successful withdrawal of the stent delivery system with final residual stenosis < 50%.
In-hospital
Proximal Late Loss
Time Frame: at 240 days
Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement)
at 240 days
Distal Late Loss
Time Frame: 240 days
Distal MLD post-procedure minus distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)
240 days
In-stent Late Loss
Time Frame: at 240 days
In-stent MLD post-procedure minus in-stent MLD at follow-up (in-stent defined as within the margins of the stent)
at 240 days
% Volume Obstruction (% VO)
Time Frame: at 240 days
Defined as stent intimal hyperplasia and calculated as 100*(Stent Volume - Lumen Volume)/Stent Volume by IVUS.
at 240 days
In-stent % Diameter Stenosis (% DS)
Time Frame: at 240 days
In-stent: Within the margins of the stent, the value calculated as 100 * (1 - in-stent MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
at 240 days
In-segment % Diameter Stenosis (% DS)
Time Frame: 240 days
Within the margins of the stent, 5 mm proximal and 5 mm distal to the stent, the value calculated as 100 * (1 - in-segment MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
240 days
Target Vessel Failure (TVF)
Time Frame: 5 years

The composite endpoint comprised of:

  • Cardiac death (death in which a cardiac cause cannot be excluded)
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
  • Ischemia-driven target vessel revascularization (TVR) by CABG or PCI
5 years
Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time Frame: 5 years

Revascularization @ target lesion associated w/ any of following:

(+) functional ischemia study Ischemic symptoms & angiographic diameter stenosis ≥50% by core lab quantitative coronary angiography (QCA) Revascularization of a target lesion w/ angiographic diameter stenosis ≥70% by core laboratory QCA without angina or (+) functional study
5 years
Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time Frame: 5 years

Revascularization at the target vessel associated with any of the following

  • Positive functional ischemia study
  • Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
  • Revascularization of a target vessel with angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study

Derived from Non-Hierarchical Subject Counts of Adverse Events
5 years
Ischemia Driven Major Adverse Cardiac Event (MACE)
Time Frame: 5 years

The composite endpoint comprised of:

  • Cardiac death
  • Myocardial infarction (MI, classified as Q-wave and non-Q wave)
  • Ischemia-driven target lesion revascularization (TLR) by CABG or PCI
5 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, MD, 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

June 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

November 23, 2011

Last Update Submitted That Met QC Criteria

November 16, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-360

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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