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

Exclusion Criteria

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