The Clinical Evaluation of the Cinatra™ Corolimus-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries

Exclusion Criteria

• •1. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, chromium, stent coatings (i.e. fatty acids, glycerides, and alpha tocopherol), or a sensitivity to contrast media, which cannot be adequately pre-medicated
• •2. History of an allergic reaction or significant sensitivity to drugs such as , zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
• •3. Platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a white blood cell (WBC) count \< 3,000 cells/mm³ within 7 days prior to index procedure
• •4. Serum creatinine level 170 micromol/L within 7 days prior to index procedure
• •5. Evidence of an acute myocardial infarction (MI) within 72 hours of the intended trial procedure (defined as: Q wave myocardial infarction (QWMI) or non-Q wave myocardial infarction (NQWMI) having CK enzymes \> 2X the laboratory upper limit of normal with the presence of an elevated CK-MB (any amount above the laboratory upper limit of normal)
• •6. Previous PCI of the target vessel within 9 months prior to the procedure
• •7. Any planned additional PCI procedure within 30 days post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure
• •8. During the index procedure, the target and/or non-target lesion(s) requires treatment with a device other than PTCA prior to stent placement (including, but not limited to, cutting balloon, atherectomy, thrombectomy, etc.)
• •9. Left ventricular ejection fraction (LVEF) \< 30% if evaluated, or clinical evidence of significant congestive heart failure (NYHA Class III or IV) within the prior 30 days
• •10. History of a stroke or transient ischemic attack (TIA) within the prior 6 months
• •11. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
• •12. History of bleeding diathesis or coagulopathy or will refuse blood transfusions
• •13. Concurrent medical condition with a life expectancy of less than 12 months
• •14. Any previous treatment of the target vessel(s) for restenosis, including brachytherapy
• •16\. Any condition which, in the Investigator's opinion, may interfere with the subject's optimal participation in the study 17. Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures
• •Angiographic:
• •1. Target lesion is located in native vessel distal to anastomosis with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass with more than 40% diameter stenosis anywhere within the graft
• •2. Previous stenting in the target vessel.
• •3. The target vessel has other lesions with greater than 40% diameter stenosis based on visual estimate or on-line QCA
• •4. The target vessel has evidence of thrombus
• •5. The target vessel is excessively tortuous (two bends \> 90º to reach the target lesion)
• •6. The target lesion has any of the following characteristics:
• •* Lesion location is aorto-ostial, an unprotected left main lesion, or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX)
• •* Involves a side branch \> 2.0 mm in diameter
• •* Is at or distal to a \> 45º bend in the vessel
• •* Is severely calcified
• •7. Unprotected left main coronary artery disease (an obstruction greater than 50% in the left main coronary artery)