Diabetes Drug Eluting Sirolimus Stent Experience in Restenosis Trial

Exclusion Criteria

• •1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
• •2. Unprotected left main coronary disease with ≥50% stenosis;
• •3. Significant (\>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
• •4. Have a target lesion in an arterial or venous by-pass graft;
• •5. Calcified lesion which cannot be successfully predilated;
• •6. Documented left ventricular ejection fraction ≤ 30%;
• •7. TIMI 0-I coronary flow ;
• •8. Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;
• •9. Pretreatment with devices other than balloon angioplasty;
• •10. Target lesion has excessive tortuousity or angulation (\>45°) which makes it unsuitable for stent delivery and deployment;
• •11. Target lesion involves bifurcation including a diseased side branch ≥2 mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting;
• •12. Prior stent within 5mm of target lesion;
• •13. Direct Stenting;
• •14. Recipient of heart transplant;
• •15. Patient with a life expectancy less than 12 months;
• •16. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix), heparin and GPIIb IIIa inhibitors (Tirofiban or Abciximab) stainless steel, contrast agent (that cannot be managed medically), or sirolimus;
• •17. Recent (6 months) cerebrovascular accidents or intracranial hemorrhage;
• •18. Any significant medical condition which in the investigator.s opinion may interfere with the patient.s optimal participation in the study;
• •19. Currently participating in an investigational drug or another device study;
• •20. Intervention of another lesion has occurred within 6 months before the index procedure;
• •21. In the investigator.s opinion, the lesion is not suitable for stenting.