Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions

Exclusion Criteria

• •Known hypersensitivity to paclitaxel.
• •Any previous 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 in the treatment of the target vessel.
• •Previous or planned treatment with intravascular brachytherapy in the target vessel.
• •Recent MI.
• •CK-MB greater than 2x the local laboratory's upper limit of normal.
• •Cerebrovascular accident within 6 months of randomization.
• •Planned CABG ≤ 9 months post index procedure.
• •Acute or chronic renal dysfunction.
• •Leukopenia.
• •Thrombocytopenia or thrombocytosis.
• •Active peptic ulcer or active gastrointestinal bleeding, or previously active within 6 months.
• •Known allergy to stainless steel.
• •Any prior true anaphylactic reaction to contrast agents.
• •Contraindication to ASA or to both clopidogrel and ticlopidine.
• •Patient was on warfarin or it was anticipated that treatment with warfarin would have been required during any period within 6 months post the index procedure.
• •Patient was or had been treated with chemotherapeutic agents within 12 months of the index procedure.
• •Anticipated treatment with paclitaxel, oral rapamycin or colchicine during any period in the 9 months post index procedure.
• •Male or female with known intention to procreate within 3 months post index procedure.
• •Co-morbid condition(s) that could limit the patient's ability to participate in the study, limit compliance with follow-up requirements or impact the scientific integrity of the study.
• •Planned surgical procedure requiring withdrawal of any anti-platelet therapy within 6 months post index procedure.
• •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.
• •Unprotected left main coronary artery disease.
• •Target lesion was ostial in location.
• •Target lesion and/or target vessel proximal to the target lesion was moderately or severely calcified.
• •Target lesion was located within or distal to a \> 60° bend in the vessel.
• •Side branch of the target lesion included ostial narrowing ≥ 50% DS and was ≥ 2.0 mm diameter.
• •Target lesion was totally occluded.
• •Angiographic presence of probable or definite thrombus.