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Status:

COMPLETED

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

Lead Sponsor:

Boston Scientific Corporation

Conditions:

Coronary Artery Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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 ...

Eligibility Criteria

Inclusion

  • General
  • Patient is ≥18 years old.
  • Eligible for percutaneous coronary intervention (PCI)
  • Documented stable angina pectoris or unstable angina pectoris with documented ischemia or documented silent ischemia
  • Left ventricular ejection fraction (LVEF) of \>/=25%
  • Acceptable candidate for coronary artery bypass grafting (CABG)
  • Patient or legal guardian understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
  • Willing to comply with all specified follow-up evaluations
  • Angiographic
  • Only one lesion (target lesion) may be treated with the study stent. However, one additional lesion in a non-target vessel may be treated during the index procedure with a commercially available bare metal stent, heparin-coated stent or TAXUS Express stent.
  • Target lesion enrolled for treatment may be composed of multiple lesions (not more than 10mm between diseased segments)but must be completely covered by one study stent.
  • Target lesion located within a single native coronary artery
  • Cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate)
  • RVD of ≥2.5 mm to ≤4.0 mm (visual estimate)
  • Target lesion diameter stenosis ≥50% (visual estimate)
  • Target lesion is de novo (i.e., a coronary lesion not previously treated)
  • General

Exclusion

  • Known hypersensitivity to paclitaxel
  • Any previous, concurrent or planned treatment with a non-study anti-restenotic drug-coated or drug-eluting coronary stent.
  • 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
  • Previous or planned treatment with intravascular brachytherapy in the target vessel
  • Planned CABG ≤9-months post-index procedure
  • MI within 72 hours prior to the index procedure and or creatine kinase(CK) \>2x the local laboratory's ULN unless CK-MB is \<2x ULN.
  • Cerebrovascular Accident (CVA) within the past 6 months
  • Cardiogenic Shock
  • Acute or chronic renal dysfunction
  • Contraindication to ASA, or to both clopidogrel and ticlopidine
  • Leukopenia
  • Thrombocytopenia or thrombocytosis
  • Active peptic ulcer or active gastrointestinal (GI) bleeding
  • Known allergy to stainless steel
  • Any prior true anaphylactic reaction to contrast agents
  • Patient is currently, or has been treated with paclitaxel or other chemotherapeutic agents within 12-months of the index procedure
  • Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
  • Male or female with known intention to procreate within 3 months after the index procedure
  • Female of childbearing potential with a positive pregnancy test within 7 days before the index procedure, or lactating, or intends to become pregnant during the study.
  • Life expectancy of less than 24-months due to other medical condition
  • Co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
  • Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
  • Angiographic

Key Trial Info

Start Date :

August 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2010

Estimated Enrollment :

871 Patients enrolled

Trial Details

Trial ID

NCT00371709

Start Date

August 1 2004

End Date

March 1 2010

Last Update

February 2 2012

Active Locations (62)

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Page 1 of 16 (62 locations)

1

Baptist Medical Center Princeton Cardiology PC

Birmingham, Alabama, United States, 35211

2

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

3

Brotman Medical Center

Beverly Hills, California, United States, 90210

4

Mercy General Hospital

Sacramento, California, United States, 95819