A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels

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 historical control groups. The first control group consists of a subset of lesion-matched TAXUS V patients treated with a 2.25 mm TAXUS Express-SR paclitaxel-eluting stent. The objective of this analysis is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions versus the TAXUS Express-SR stent. The hypothesis is that the TAXUS Liberté-SR stent has non-inferior safety and efficacy to the TAXUS Express-SR stent in the treatment of de novo lesions in small coronary vessels. The second control group consists of a subset of lesion-matched TAXUS V patients treated with either a 2.5 mm or a 2.25 mm bare metal Express stent. The objective of this analysis is to evaluate clinical and angiographic outcomes of TAXUS Liberté-SR 2.25 mm stent in de novo lesions versus the Express bare metal stent. The hypothesis is that the TAXUS Liberté-SR stent has superior safety and efficacy to the Express bare metal stent in the treatment of de novo lesions in small coronary vessels.

General Inclusion Criteria:

• 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 Inclusion Criteria:

• 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 Criteria:

• 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 Exclusion Criteria:

• Unprotected and protected left main coronary artery disease (patient with protected left main disease can be enrolled ONLY if the target lesion is in the RCA)
• Target lesion is ostial in location (within 3.0 mm of vessel origin)
• Target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified by visual estimate
• Target lesion and/or target vessel proximal to the target lesion is tortuous
• Target lesion is located within or distal to a >60 degree bend in the vessel
• Target lesion involves a bifurcation with a side branch vessel >1.5 mm (visual estimate)
• Target lesion is totally occluded (TIMI flow <1), either at baseline or predilation
• Angiographic presence of probable or definite thrombus
• Pre-treatment of teh target vessel at the index procedure is not allowed with any device except for predilation with balloon angioplasty or cutting balloon
• A previously treated lesion within the target vessel:

• <15mm from the target lesion (visual estimate)
• Performed </= 6 months from index procedure
• >30% residual stenosis after previous treatment