SERIES III RUN-IN Clinical Trial: A Comparison of the Supralimus® Stent With the Xience V™ Stent

Exclusion Criteria

• •6. The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.
• •7. The target lesion must be ≤ 22 mm in length by visual estimate.
• •8. The target reference vessel diameter must be ≥ 2.5 mm and ≤ 3.5 mm.
• •9. Patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the clinical site.
• •1. Female of childbearing potential
• •2. Documented left ventricular ejection fraction (LVEF) ≤ 30%
• •3. Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure
• •4. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®, Ceruvin) or ticlopidine (Ticlid®), heparin, sirolimus, everolimus, stainless steel, cobalt, chromium, contrast agent (that cannot be adequately pre-medicated)
• •5. A platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a WBC \<3,000 cells/mm3
• •6. Acute or chronic renal dysfunction (creatinine \>2.0mg/dl or \>150µmol/L)
• •7. Total occlusion (TIMI 0) or TIMI 1
• •8. Target vessel has evidence of thrombus
• •9. Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment
• •10. Previous bare metal stenting (less than 1 year) anywhere within the target vessel
• •11. Previous drug-eluting stenting anywhere within any epicardial vessel
• •12. The target lesion requires treatment with a device other than PTCA prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
• •13. Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off
• •14. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated
• •15. Target lesion is located in or supplied by an arterial or venous bypass graft
• •16. Ostial target lesion
• •17. Target lesion involves a side branch \>2.0mm in diameter with an ostial disease
• •18. Patient is currently participating in an investigational drug or device study, including its follow-up period
• •19. Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind
• •20. Within 60 days post-procedure, patient requires planned interventional treatment of any non-target vessel. Planned intervention of the target vessel after the index procedure is not allowed.
• •21. Stroke or transient ischemic attack within the prior 6 months
• •22. Unprotected Left Main (LM) coronary artery disease (stenosis \>50%)
• •23. In the investigator's opinion, patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
• •24. Planned surgery within 6 months after the index procedure
• •25. Life expectancy less than 1 year