Study to Evaluate the Safety of Cronus® - Cobalt Chromium Coronary Stent

Exclusion Criteria

• •1. Female patients of childbearing potential;
• •2. Recent Q-wave myocardial infarction occurred within 48 hours prior to the index procedure. Recent Q-wave or non-Q-wave myocardial infarction with still elevated levels of cardiac markers;
• •3. Documented left ventricular ejection fraction \<30%;
• •4. Renal dysfunction (creatinine \> 2.0 mg/dL or 177 µmol/L);
• •5. Platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³.;
• •6. White blood cell count \<3,000 cells/mm3;
• •7. Suspected or documented hepatic disease (including laboratorial evidence of hepatitis);
• •8. Heart transplant receptor;
• •9. Known hypersensitivity to cobalt-chromium or to medications such as aspirin, clopidogrel bisulfate (Plavix or ISCOVER), ticlopidine (Ticlid) or heparin.
• •10. Concurrent medical condition with a life expectancy of less than 12 months;
• •11. Any major medical condition that, in the Investigator's opinion, may interfere with the optimal participation of the patient in this study;
• •12. Subject is currently participating in an investigational drug or another device study, including planned participation in an investigational drug or another device study during the course of the present investigation;
• •13. Coronary angioplasty (with or without stenting) less than 9 months before the index procedure at any site of the target vessel;
• •14. Previous coronary angioplasty (with or without stenting) at any time (\>9 months) in a vessel segment less than 5 mm proximal or distal to the target lesion.
• •15. Planned coronary angioplasty (with or without stenting) in the first 12 months after the index procedure in any segment of the target vessel;
• •1. Restenotic target lesion;
• •2. More than one lesion requiring treatment in the same vessel;
• •3. Target vessel diameter \<2.5 mm or \>3.5 mm (by visual estimation);
• •4. Long target lesion not amenable to treatment (coverage) with a 19-mm-long stent;
• •5. Unprotected coronary artery branch lesion (≥50% diameter stenosis)
• •6. Target lesion is located in a surgical bypass graft;
• •7. Total vessel occlusion (TIMI flow grade 0-1);
• •8. Target lesion with ostial location;
• •9. Target lesion located in a lateral branch bifurcation \>2.5mm or requiring lateral branch stenting;
• •10. Calcified target lesion that anticipates unsuccessful/impracticable predilation;
• •11. Target vessel with excessive tortuosity