Study Safety and Performance of the Biomime Stent in Patients With Single, De Novo, Non-Complex Coronary Lesions

Inclusion Criteria: * Patient with \> 18 years of age; * Symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia; * Presence of a single de novo target lesion located in a native coronary vessel suitable for percutaneous treatment with the study stents; * Acceptable candidate for coronary artery bypass graft (CABG) surgery; * The subject is willing to sign a written informed consent prior to procedure, and is willing to undergo ALL study protocol follow-ups, including angiographic (and IVUS) follow-ups at 8 months. * Target lesion located in a major epicardial coronary vessel with reference of 2.5-3.5mm in diameter (by visual estimation) * Target lesions ≤ 19mm in length (by visual estimation) that can be treated (covered) by one single study stent (19 or 24mm in length); * ≥ 50% and \< 100% diameter stenosis; * TIMI (Thrombolysis In Myocardial Infarction) flow grade ≥ 2. Exclusion Criteria: * Known hypersensitivity or contraindication to mTOR inhibitor class drugs (sirolimus), heparin, any required medications including thienopyridines, cobalt chromium, and contrast media which cannot be adequately pre medicated; * Patient is a female with childbearing potential; * Pre-treatment of the target lesion with any devices other than balloon angioplasty; * Previous brachytherapy in the target vessel; * Presence of non-target vessel lesions which require staged procedure(s) \< 30 days of the index procedure; * Prior CABG surgery to target vessel; * Previous percutaneous coronary intervention (PCI) or CABG surgery \< 30 days to the index procedure date; * Acute myocardial infarction \< 3 days, with cardiac enzyme elevation including total creatine kinase (CK) \> 2 times the upper normal limit value and/or CK-MB above the upper normal limit value within the past 72 hours; * CK and/or CK-MB levels elevated above the upper normal limit value at the time of the index procedure; * Documented left ventricular ejection fraction \< 30%; * Renal insufficiency determined by a baseline serum creatinine \> 2.0/dl; * Thrombocytopenia with a baseline platelet count \< 100,000 cells/mm3; * Anemia with baseline hemoglobin \< 10g/dL; * Extensive peripheral vascular disease or extreme anticoagulation that precludes safe \> 5 French sheath insertion; * History of bleeding diathesis, coagulopathy, or will refuse blood transfusions; * Patients has suffered a stroke, transient ischemic attack (TIA), or cerebrovascular accident (CVA) within the past 6 months; * Significant gastrointestinal or genitourinary bleed within the past 6 months; * Patient is a recipient of a heart transplant; * Any elective surgical procedure is planned within 12 months of the index procedure; * Known illness or any serious clinical condition with life expectancy \< 2 years; * Participation in the active or follow-up phase of any other clinical trial within 6 months; * Impossibility to comply with anti-platelet therapy during the study clinical follow-up; * Any impossibility to comply with all protocol follow-ups. * Target lesion or vessel with angiographic evidence of moderate or severe calcification; * Presence of severe tortuosity; * Presence of severe angulation (\> 60o); * Presence of intraluminal thrombus; * Target lesion involving a bifurcation (side branch ≥ 2.0mm); * Target lesion located in the left main stem; * Aorto-ostial lesion location; * Target lesion involving a side branch with reference diameter ≥ 2.0mm; * Presence of a significant stenosis (\> 40%) in the target vessel either proximal or distal to the target lesion that will be untreated; * Previous placement of a stent within 10mm of the target lesion; * Total occlusion (TIMI flow grade 0 or 1); * Target lesion located in an arterial or vein graft; * Target lesion due to in-stent restenosis; * Coronary anatomy unsuitable for percutaneous treatment with implantation of the available study stents.