TAXUS ATLAS: TAXUS Liberté™-SR Stent for the Treatment of de Novo Coronary Artery Lesions

Last updated: February 1, 2012
Sponsor: Boston Scientific Corporation
Overall Status: Completed

Phase

3

Condition

Myocardial Ischemia

Coronary Artery Disease

Heart Disease

Treatment

N/A

Clinical Study ID

NCT00371709
S2013
TAXUS ATLAS
  • Ages > 18
  • All Genders

Study Summary

TAXUS ATLAS is a global, multi-center, single-arm, non-inferiority trial comparing results from patients treated with the TAXUS Liberté stent to an historical TAXUS Express control. The control group is a case-matched, blended population of TAXUS Express patients from the TAXUS IV and TAXUS V de novo clinical trials. The objective of the study is to evaluate clinical outcomes of TAXUS Liberté-SR stent in de novo lesions and to assess the non-inferiority of TAXUS Liberté versus TAXUS Express. The TAXUS Liberté-SR stent is hypothesized to have comparable safety and efficacy to the TAXUS Express stent.

Eligibility Criteria

Inclusion

General Inclusion Criteria:

  1. Patient is ≥18 years old.

  2. Eligible for percutaneous coronary intervention (PCI)

  3. Documented stable angina pectoris or unstable angina pectoris with documented ischemiaor documented silent ischemia

  4. Left ventricular ejection fraction (LVEF) of >/=25%

  5. Acceptable candidate for coronary artery bypass grafting (CABG)

  6. Patient or legal guardian understands the study requirements and the treatmentprocedures and provides written Informed Consent before any study-specific tests orprocedures are performed

  7. Willing to comply with all specified follow-up evaluations Angiographic Inclusion Criteria:

  8. Only one lesion (target lesion) may be treated with the study stent. However, oneadditional lesion in a non-target vessel may be treated during the index procedurewith a commercially available bare metal stent, heparin-coated stent or TAXUS Expressstent.

  9. Target lesion enrolled for treatment may be composed of multiple lesions (not morethan 10mm between diseased segments)but must be completely covered by one study stent.

  10. Target lesion located within a single native coronary artery

  11. Cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate)

  12. RVD of ≥2.5 mm to ≤4.0 mm (visual estimate)

  13. Target lesion diameter stenosis ≥50% (visual estimate)

  14. Target lesion is de novo (i.e., a coronary lesion not previously treated)

Exclusion

General Exclusion Criteria:

  1. Known hypersensitivity to paclitaxel

  2. Any previous, concurrent or planned treatment with a non-study anti-restenoticdrug-coated or drug-eluting coronary stent.

  3. Previous or planned use of both the study stent and a non-study stent (i.e.,commercial stent) in the treatment of the target vessel

  4. Previous or planned treatment with intravascular brachytherapy in the target vessel

  5. Planned CABG ≤9-months post-index procedure

  6. MI within 72 hours prior to the index procedure and or creatine kinase(CK) >2x thelocal laboratory's ULN unless CK-MB is <2x ULN.

  7. Cerebrovascular Accident (CVA) within the past 6 months

  8. Cardiogenic Shock

  9. Acute or chronic renal dysfunction

  10. Contraindication to ASA, or to both clopidogrel and ticlopidine

  11. Leukopenia

  12. Thrombocytopenia or thrombocytosis

  13. Active peptic ulcer or active gastrointestinal (GI) bleeding

  14. Known allergy to stainless steel

  15. Any prior true anaphylactic reaction to contrast agents

  16. Patient is currently, or has been treated with paclitaxel or other chemotherapeuticagents within 12-months of the index procedure

  17. Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure

  18. Male or female with known intention to procreate within 3 months after the indexprocedure

  19. Female of childbearing potential with a positive pregnancy test within 7 days beforethe index procedure, or lactating, or intends to become pregnant during the study.

  20. Life expectancy of less than 24-months due to other medical condition

  21. Co-morbid condition(s) that could limit the patient's ability to participate in thestudy, compliance with follow-up requirements or impact the scientific integrity ofthe study

  22. Currently participating in another investigational drug or device study that has notcompleted the primary endpoint or that clinically interferes with the endpoints ofthis study. Angiographic Exclusion Criteria:

  23. Left main coronary artery disease (stenosis >50%) whether protected or unprotected

  24. Target lesion is ostial in location (within 3.0 mm of vessel origin)

  25. Target lesion and/or target vessel proximal to the target lesion is moderately orseverely calcified by visual estimate.

  26. Target lesion and/or target vessel proximal to the target lesion is tortuous.

  27. Target lesion is located within or distal to a >60 degree bend in the vessel

  28. Target lesion involves a bifurcation with a side branch vessel >2.0 mm in diameter.

  29. Target lesion is totally occluded (TIMI flow </= 1), either at baseline or predilation

  30. Angiographic presence of probable or definite thrombus

  31. Pre-treatment of the target vessel is not allowed with any device

Study Design

Total Participants: 871
Study Start date:
August 01, 2004
Estimated Completion Date:
March 31, 2010

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Box Hill Hospital

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Cardiovascular Research Center Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Epworth Hospital

    Richmond, Victoria 3121
    Australia

    Site Not Available

  • Foothills Medical Centre

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • Vancouver General

    Vancouver, British Columbia V5Z 1L8
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • CHUM Notre-Dame Hospital

    Montreal, Quebec H2L 4M1
    Canada

    Site Not Available

  • Montreal Heart Institute

    Montreal, Quebec H1T 1C8
    Canada

    Site Not Available

  • Queen Elizabeth Hospital

    Kowloon,
    China

    Site Not Available

  • Mercy Angiography Unit, 98 Mountain Road, First Floor

    Auckland, Epsom 1003
    New Zealand

    Site Not Available

  • Auckland City Hospital

    Auckland, 1030
    New Zealand

    Site Not Available

  • Christchurch Hospital

    Christchurch,
    New Zealand

    Site Not Available

  • Dunedin Hospital

    Dunedin,
    New Zealand

    Site Not Available

  • National Heart Centre

    Singapore, 168752
    Singapore

    Site Not Available

  • National University Hospital

    Singapore, 119074
    Singapore

    Site Not Available

  • Shin Kong Memorial Hospital

    Shih Lin Taipei 111,
    Taiwan

    Site Not Available

  • Cathay General Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei,
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei 100,
    Taiwan

    Site Not Available

  • Chang-Gung Memorial Hospital, Kaohsiung

    Taiwan, 83305
    Taiwan

    Site Not Available

  • Chang-Gung Memorial Hospital, Linkou

    Tao-Yuan,
    Taiwan

    Site Not Available

  • Baptist Medical Center Princeton Cardiology PC

    Birmingham, Alabama 35211
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Brotman Medical Center

    Beverly Hills, California 90210
    United States

    Site Not Available

  • Mercy General Hospital

    Sacramento, California 95819
    United States

    Site Not Available

  • Salinas Valley Memorial Healthcare System

    Salinas, California 93901
    United States

    Site Not Available

  • University of California San Diego Medical Center

    San Diego, California 92103-8784
    United States

    Site Not Available

  • St. Joseph's Medical Center

    Stockton, California 95204
    United States

    Site Not Available

  • The Medical Center of Aurora

    Aurora, Colorado 80012
    United States

    Site Not Available

  • Christiana Hospital

    Newark, Delaware 19718-0002
    United States

    Site Not Available

  • George Washington University Medical Center

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Florida Hospital

    Orlando, Florida 32803
    United States

    Site Not Available

  • Rockford Cardiology Associates

    Rockford, Illinois 61108
    United States

    Site Not Available

  • Praire Cardiovascular Consultants, Ltd.

    Springfield, Illinois 62701
    United States

    Site Not Available

  • The Heart Center

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • Willis Knighton Medical Center

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Maine Medical Center

    Portland, Maine 04102
    United States

    Site Not Available

  • Washington Adventist Hospital

    Takoma Park, Maryland 20912
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Genesys Regional Medical Center

    Grand Blanc, Michigan 48439
    United States

    Site Not Available

  • Northern Michigan Hospital

    Petoskey, Michigan 49770
    United States

    Site Not Available

  • St. Mary's Duluth Clinic Regional Heart Center

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • North Mississippi Medical Center

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Dartmouth Hitchcock Cardiology

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • New York Presbyterian Hospital

    New York, New York 10021
    United States

    Site Not Available

  • WakeMed

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • Good Samaritan Hospital

    Cincinnati, Ohio 45220
    United States

    Site Not Available

  • Riverside Methodist Hospital

    Columbus, Ohio 43214
    United States

    Site Not Available

  • North Ohio Research Elyria Memorial Hospital

    Elyria, Ohio 44035
    United States

    Site Not Available

  • Oklahoma Foundation for Cardiovascular Research

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • The Pennsylvania State University Milton S Hershey Medical Center

    Hershey, Pennsylvania 17033-0850
    United States

    Site Not Available

  • Hospital of University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Baptist Memorial Hospital

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Methodist DeBakey Heart Center

    Houston, Texas 77030-2767
    United States

    Site Not Available

  • Scott & White Memorial Hospital

    Temple, Texas 76508
    United States

    Site Not Available

  • St. Peter Hospital

    Olympia, Washington 98506
    United States

    Site Not Available

  • Northwest Cardiovascular Research Institute-Spokane Cardiology

    Spokane, Washington 99204
    United States

    Site Not Available

  • Sacred Heart Medical Center

    Spokane, Washington 99220
    United States

    Site Not Available

  • Aurora St Lukes Medcial Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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