Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety

This trial aims to demonstrate the non-inferiority of the CI-CMS-005 Coronary Stent System to the study device as well as to the TAXUS™ Express2™ Drug-Eluting Coronary Stent System in in-segment late lumen loss at 9 months after treatment of a single de novo lesion per vessel.

This is a complementary, multi-center, open-label, single-arm trial investigating angiographic and clinical patient outcomes in Japan. Historical data from the 2-arm randomized COSTAR II trial will be used for comparison.

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.
• 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 ticlopidine
• Thrombocytopenia
• Active GI bleeding within past three months
• Known allergy to cobalt chromium
• Any prior true anaphylactic reaction to contrast agents