Status:
COMPLETED
A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
TAXUS ATLAS Small Vessel is a global, multi-center, single-arm, trial of patients with coronary arteries less than 2.5 mm in diameter who are treated with the TAXUS Liberté stent versus an historical ...
Detailed Description
TAXUS ATLAS Small Vessel is a global, multi-center, single-arm, trial of patients receiving the TAXUS Liberté-SR 2.25 mm paclitaxel-eluting stent. The results will be compared with two different histo...
Eligibility Criteria
Inclusion
- General
- Patient is at least 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 at least 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 avaiable bare metal stent, heparin-coated stent or TAXUS Express stent.
- Successful predilation is mandatory for entry into study
- Target lesion located within a single native coronary artery
- 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 greater than or equal to 10 mm and less than or equal to 28 mm (visual estimate)
- Target lesion RVD of 2.25 mm \[2.2 - 2.5 mm (visual estimate)\]
- Target lesion diameter stenosis at least 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.
- 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 within 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
- 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 :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT00371748
Start Date
February 1 2005
End Date
April 1 2011
Last Update
February 2 2012
Active Locations (25)
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1
Mercy General Hospital
Sacramento, California, United States, 95819
2
Christiana Hospital
Newark, Delaware, United States, 19718-0002
3
Florida Hospital
Orlando, Florida, United States, 32803
4
St. John's Hospital
Springfield, Illinois, United States, 62701