Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)

Non -inferiority in 8-month Major Adverse Cardiac Events (MACE) and in-segment late lumen loss at 9 months between the CoStar™ Paclitaxel-Eluting Coronary Stent System and the TAXUS™ Express2™ Drug Eluting Coronary Stent System for the treatment of a single de novo lesion per vessel in patients with single and multi-vessel coronary disease.

Inclusion criteria

General Inclusion Criteria:

• Eligible for percutaneous coronary intervention (PCI)
• Documented stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia
• Documented LVEF ≥25% within the last 6 weeks.
• Eligible for coronary artery bypass graft surgery (CABG)

Exclusion criteria

General Exclusion Criteria:

• Known sensitivity to paclitaxel or polymeric matrices: Translute or PLGA.
• Planned treatment with any other PCI device in the target vessel(s).
• MI within 72 hours prior to the index procedure
• Patient is in cardiogenic shock
• Cerebrovascular Accident (CVA) within the past 6 months
• Acute or chronic renal dysfunction (creatinine >2.0 mg/dl or >150 µmol/L)
• Contraindication to ASA or to clopidogrel
• Thrombocytopenia
• Active GI bleeding within past three months
• Known allergy to stainless steel or cobalt chromium
• Any prior true anaphylactic reaction to contrast agents
• Patient is currently taking colchicine