GISSOC II: Sirolimus Eluting Stent Versus Bare Metal Stent in Chronic Total Coronary Occlusions

Inclusion Criteria: Stable or unstable angina pectoris or documented silent ischemia; Planned treatment of a single de novo chronic totally occluded (CTO) in a native coronary artery with a reference diameter between 2.75 mm and 3.75 mm; The target lesion can be fully covered by ≤ 2 stents of ≤33 mm of length each; The target CTO is at least 30 days old; The target CTO is successfully crossed by a guide wire and dilated by a balloon; Exclusion Criteria: Myocardial infarction within 30 days in the territory of the target CTO; Unprotected left main coronary artery disease; Target CTO is in a graft; Target CTO is in a stented segment; Presence of other lesions in the same vessel,requiring angioplasty and not treatable with the same stent(s) used for the target CTO; More than one CTO requiring PCI; Target CTO has diseased side branches >2.0 mm in diameter; Target CTO pretreated with non-balloon devices such as atherectomy or laser or thrombectomy devices; Patient treated with coronary brachytherapy; The patient has an ejection fraction ≤ 30%; The patient has impaired renal function (creatinine > 3.0 mg/dl); The patient has known allergies to aspirin, clopidogrel bisulfate and ticlopidine, heparin, or sirolimus, contrast media or stainless steel that cannot be managed medically; The patient needs therapy with warfarin; The patient has a life expectancy less than 24 months; Recipient of heart transplant; The patient is currently participating in an investigational drug or another device study.