Safety Study to Assess the Feasibility of Use in Humans of the TAXUS Petal Bifurcation Coronary Stent System

Inclusion Criteria - Phases 1 and 2

• Age is ≥18 years old and ≤80 years old
• Eligible for PCI
• Acceptable candidate for CABG
• Documented stable angina pectoris (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
• LVEF known to be ≥40%
• Clinical angiographic success in non-target lesion (if a non-target lesion is treated)
• Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed
• Subject willing to comply with follow-up evaluations

Exclusion Criteria - Phases 1 and 2

• Contraindication to ASA, or to Thienopyridine derivatives (e.g. Clopidogrel, Ticlopidine)
• High risk of bleeding
• 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 BMS within 9 months before index procedure
• Previous treatment of any non-target vessel with any anti-restenotic drug-coated or DES within 9 months before index procedure
• Previous treatment with intravascular brachytherapy in the target vessel
• Planned PCI or CABG post-index procedure
• Planned target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter
• Documented MI within 72 hours prior to index procedure
• CK > 2 x ULN + positive CK-MB OR
• CK > 2 x ULN + positive troponin OR
• If no CK-MB or troponin was drawn, patients are excluded with CK > 2xULN
• As per protocol definitions found in Appendix A:
• 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 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 within 9 months of index procedure
• Subject's (men and women) known intention to procreate within 9 months of index procedure
• Positive pregnancy test or nursing an infant within 7 days prior to index procedure
• 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 or impact study scientific integrity
• Currently participating in another investigational drug or device clinical study
• Planned surgery at time of enrollment within the next 9 months after index procedure

Angiographic Inclusion Criteria - Phases 1 & 2

• Target Lesion (main and / or side branch):
• located in native coronary artery
• must be de novo
• main branch %DS is ≥50% and <100%
• is a bifurcation lesion with an angle ≥30º and ≤90º
• is enrolled after successful pre-dilatation of the target vessel

Angiographic Inclusion Criteria - Phase 1

• Main branch of target lesion located in parent branch of LAD or LCx or RCA
• Target lesion located in proximal or mid-section of vessel only (crux of RCA [distal RCA] is allowed)
• Main branch RVD ≥3.00 mm to ≤3.5 mm; lesion length ≤20 mm (to be covered by TAXUS® Petal™ stent and maximum of 1 additional TAXUS stent ≤12 mm in length)
• Side branch RVD ≥2.5 mm to ≤3.5 mm; lesion length ≤14 mm to be treated by maximum of 1 TAXUS stent ≤16 mm in length Angiographic Inclusion Criteria - Phase 2
• Main branch of target lesion located in parent branch of LAD or LCx or RCA without restrictions
• Main branch RVD ≥3.00 mm to ≤3.5 mm; lesion length ≤28 mm (to be covered by TAXUS® Petal™ stent and maximum of 1 additional TAXUS stent ≤20 mm in length)
• Side branch RVD ≥2.25 mm to ≤3.5 mm; lesion length ≤14 mm to be treated by maximum of 1 TAXUS stent ≤16 mm in length

Angiographic Exclusion Criteria - Phases 1 & 2

• Target lesion located in left main (protected or unprotected)
• Medina Classification 0.0.1
• Target lesion is restenotic
• Target lesion located in a SVG or mammary artery graft
• Target lesion accessed via SVG or mammary artery graft
• Target lesion is <5 mm from BMS
• Target lesion is <5 mm from second side branch vessel ≥1.5 mm in diameter
• Untreated lesions with ≥50% DS or thought to impair flow remaining in target vessel
• Target lesion and/or vessel proximal to target lesion moderately or severely calcified
• Target lesion and/or target vessel proximal to target lesion severely tortuous
• Main branch target lesion located within or distal to a >60° bend in target vessel
• Target vessel with angiographic presence of probable or definite thrombus
• Unprotected LM disease
• Protected LM disease with target lesion in LAD or LCx (subject may be enrolled if only lesion is target lesion in RCA)

Angiographic Exclusion Criteria

• Phase 1: Target lesion TIMI flow <3
• Phase 2: Target lesion TIMI flow <2