Diabetes Drug Eluting Sirolimus Stent Experience in Restenosis Trial

Inclusion Criteria: 1. The patient must be ≥ 18 years of age; 2. Female of childbearing potential must have a negative pregnancy test within 7days of enrollment and utilize reliable birth control for eight months after enrollment; 3. Patients with IDDM (Type I) treated for at least 3 months with documented HbA1c, or NIDDM (Type II) treated with oral antidiabetics for at least 3 months; 4. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia OR patient with previous (\>24 hours) myocardial infarction with documented residual ischemia and/or viable myocardium; 5. Single or double stent treatment of de novo lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multi-vessel disease can be included only if a maximum of two vessels require treatment with a maximum of three lesions in total, no more than two lesions per vessels. The two lesions in a single vessel must be \>10 mm apart (visual estimate) and must be treated with the assigned stent. 6. Target vessel diameter at the lesion site is ≥ 2.50mm and ≤ 3.5mm in diameter (visual estimate); 7. Target lesion is ≥ 13mm and ≤ 25mm in length (visual estimate); 8. Target lesion stenosis is \>50% and \<100% (visual estimate); 9. At least TIMI II coronary flow; 10. Acceptable candidate for coronary artery bypass surgery (CABG); 11. Patient is willing to comply with the specified follow-up evaluation; 12. Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee; 13. Patient can be pretreated with aspirin and clopidogrel or, alternatively, aspirin alone plus a loading dose of 300 mg of clopidogrel before procedure completion in case of urgent PCI, and GPIIb IIIa inhibitors (Tirofiban or Abciximab) 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.