Status:
COMPLETED
Direct Stenting of TAXUS Liberté™-SR Stent for the Treatment of Patients With 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 Direct Stent is a global, multi-center, single-arm, noninferiority trial comparing results from patients in whom the TAXUS Liberté stent was directly implanted (direct stenting) versus res...
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 appropriate for direct stenting (typically covered by one 24 mm stent or shorter), 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 located within a single native coronary vessel
- 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.
- Cumulative target lesion length is ≥10 mm and ≤28 mm (visual estimate) and is typically considered appropriate for direct stenting
- 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
- Patient is currently on warfarin or it is anticipated that treatment with warfarin will be required during any period within 6 months after the index procedure.
- Leukopenia
- Thrombocytopenia
- 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
- 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 :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT00371423
Start Date
March 1 2005
End Date
September 1 2010
Last Update
February 2 2012
Active Locations (25)
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1
University of Arkansas for Medical Sciences/Central Arkansas Veterans Healthcare Systems
Little Rock, Arkansas, United States, 72205
2
Mercy General Hospital
Sacramento, California, United States, 95819
3
University of California San Diego Medical Center
San Diego, California, United States, 92103-8784
4
The Medical Center of Aurora
Aurora, Colorado, United States, 80012