A Prospective Evaluation in a Randomized Trial of TAXUS in the Treatment of De Novo Coronary Artey Lesions

Inclusion Criteria:

Clinical Inclusion Criteria

• Subject is ≥ 18 years old and ≤ 80 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 with documented ischemia (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

Angiographic Inclusion Criteria (visual estimate)

• Target lesion located in native coronary artery
• Target lesion must be de novo
• Target lesion diameter stenosis > 50%
• Reference vessel diameter (RVD) > 2.75mm to < 4.0mm
• Cumulative target lesion length < 28 mm (area to be treated must be completely coverable by one study stent)
• Target lesion is successfully pre-dilated. Subjects are enrolled after successful balloon catheter pre-dilation of the target lesion and assignment to treatment arm by IVRS.
• One non-target lesion may be treated in a non-target vessel
• Non-target lesion in non-target vessel must be treated with a 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 stent(s).
• Treatment must be completed prior to treatment of target lesion.

Exclusion Criteria:

Clinical Exclusion Criteria

• Contraindication to 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 the index procedure as defined per protocol definition (see Appendix A)
• Cerebrovascular accident (CVA) within the past 6 months
• Cardiogenic shock characterized by systolic pressure < 80mm Hg and/or central filling pressure > 20 mm Hg, or cardiac index < 1.8 liters/minute/m2 or intra-aortic balloon pump or intravenous inotropes are needed to maintain a systolic pressure > 80 mm Hg and a cardiac index > 1.8 liters/minute/m2
• Acute or chronic renal dysfunction (creatinine > 2.0 mg/dl or 177 μmol/l)
• Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure
• Leukopenia (leukocyte count < 3.5 x 109/liter)
• Thrombocytopenia (platelet count < 100,000/mm3)
• Thrombocytosis (> 750,000/mm3)
• 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 agent(s)
• 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 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 the subject's ability to comply with study follow-up requirements or impact the scientific integrity of the study
• Currently participating in another investigational drug or device study

Angiographic Exclusion Criteria (visual estimate)

• Target lesion 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 < 5mm from bare metal stent (BMS)
• Target lesion is < 5mm from ostium
• Target lesion is < 5 mm from a side branch vessel ≥ 1.5 mm in diameter
• Untreated lesions with ≥ 50% diameter stenosis or thought to impair flow remaining in target vessel
• Target lesion and/or target vessel proximal to the target lesion is moderately or severely calcified
• Target lesion and/or target vessel proximal to the target lesion is severely tortuous
• Target lesion is located within or distal to a > 60° bend in the vessel
• Target lesion with angiographic presence of probable or definite thrombus
• Unprotected left main coronary artery disease
• Protected left main coronary artery disease with target lesion in LAD or LCx(subject may be enrolled if only lesion is target lesion in RCA)