TAXUS PERSEUS Workhorse

Clinical Inclusion Criteria:

• Subject is ≥ 18 years old
• Eligible for percutaneous coronary intervention (PCI)
• Documented stable angina pectoris (Canadian Cardiovascular Society [CCS] Classification 1, 2, 3, or 4) or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
• Acceptable candidate for coronary artery bypass grafting (CABG)
• Left ventricular ejection fraction (LVEF) is ≥ 30%
• Subject (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
• Subject willing to comply with all specified follow-up evaluations

Clinical Exclusion Criteria:

• Contraindication to aspirin (ASA), or to both clopidogrel and ticlopidine
• Known hypersensitivity to paclitaxel
• Known allergy to stainless steel
• Known allergy to platinum
• Previous treatment of the target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent
• Previous treatment of the target vessel with a bare metal stent (BMS) within 9 months of the index procedure
• Previous treatment of any non-target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent within 9 months of the index procedure
• Previous treatment with intravascular brachytherapy in the target vessel
• Planned PCI or CABG post-index procedure
• Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement
• Myocardial infarction (MI) within 72 hours prior to index procedure
• Cerebrovascular accident (CVA) within the past 6 months
• Cardiogenic shock
• Acute or chronic renal dysfunction
• Prior anaphylactic reaction to contrast agents
• Leukopenia
• Thrombocytopenia
• Thrombocytosis
• Active peptic ulcer or active gastrointestinal (GI) bleeding
• Current treatment, or past-treatment within 12-months of the index procedure, with paclitaxel or other chemotherapeutic agents
• Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
• Known intention to procreate within 9 months after the index procedure
• Positive pregnancy test within 7 days before the index procedure, or lactating
• Life expectancy of less than 24 months due to other medical conditions
• Co-morbid condition(s) that could limit subject's ability to comply with study follow-up requirements or impact study scientific integrity
• Currently participating in another investigational drug or device study

Angiographic Inclusion Criteria:

• Target Lesion
• Target lesion located in native coronary artery
• Target lesion must be de novo
• Target lesion diameter stenosis ≥ 50%
• Reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 4.0 mm
• Cumulative target lesion length ≤ 28 mm (area to be treated may be composed of multiple lesions but must be completely coverable by one study stent)
• Target lesion is successfully pre-dilated
• One non-target lesion may be treated in a non-target vessel as follows:
• Non-target lesion in non-target vessel must be treated with commercially available TAXUS stent if use of drug eluting stent required
• Treatment must be deemed a clinical angiographic success, without requiring use of unplanned additional stents(s)
• Treatment must be completed prior to treatment of target vessel

Angiographic Exclusion Criteria

• Target lesion located in left main artery, whether protected or unprotected
• Target lesion is a chronic total occlusion (TIMI flow ≤ 1)
• Target lesion is restenotic
• Target lesion is located in a saphenous vein graft or mammary artery graft
• Target lesion is accessed via saphenous vein graft or mammary artery graft
• Target lesion is 60° bend in target vessel
• Target vessel with angiographic presence of probable or definite thrombus
• Unprotected left main coronary artery disease
• Prote