Cobra II Study: Use of the Cobra™ Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease

Inclusion Criteria: * The subject is ≥ 18 years old; * Subject is eligible for percutaneous coronary intervention (PCI), stent placement, and emergent coronary artery bypass graft (CABG) surgery; * Subject has clinical evidence of ischemic heart disease, stable or unstable angina or silent ischemia; * The subject has a documented left ventricular ejection fraction (LVEF) ≥ 30%; * The subject or legal representative has been informed of the clinical study and the required follow-up procedures and must provide written informed consent using a form that is reviewed and approved by the Institutional Review Board/Ethics Committee (IRB/EC) for the clinical site; * Female subjects of childbearing potential must have a negative pregnancy test within 7 days before treatment; * Subject must agree to comply with the required follow-up procedures (including antiplatelet regimen) to the best of their ability, be geographically available for all study follow-up procedures and visits and not have a known medical condition that precludes completion of the required follow-up visits; * The lesion is either de novo or restenotic (previously unstented) in nature, located in a native coronary artery AND is ≥ 50% and \< 100% stenosed by visual estimate or on-line QCA; * The target vessel reference diameter ≥ 2.5mm and ≤ 4mm by visual estimate and is appropriate for treatment with available stent diameters of 2.5 mm, to 4.0 mm; * The lesion length is ≤ 26 mm and able to accommodate placement of a single stent; * The target lesion is a minimum of 15 mm from any previously placed stent; AND * The target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥ 2 Exclusion Criteria: * The subject has a known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, ticlopidine and clopidogrel, cobalt, nickel, chromium, molybdenum, or a sensitivity to contrast media, which cannot be adequately pre-medicated; * A platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a WBC \< 3,000 cells/mm³; * A creatinine level \> 2.5 mg/dL within 7 days prior to the index procedure; * Evidence of an acute myocardial infarction (MI) within 72 hours of the intended treatment (defined as: Q wave (QWMI) or any elevation of creatine kinase myocardial-band (CK-MB) isoenzyme elevated above the Institution's upper limit of normal; * Any previous PCI (with or without stent) of the target vessel within 30 days prior to the index procedure; * Previous stent placement anywhere in the target lesion; * Previous drug eluting stent (DES) deployment anywhere in the target vessel; * The subject requires staged procedure of any non-target vessel within 30 days post-procedure; * The subject requires staged procedure of the target vessel within 9 months post-procedure; * The target lesion requires treatment with a device other than PTCA prior to stent placement (including, but not limited to, cutting balloon, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.; * History of a stroke or transient ischemic attack (TIA) within the previous 6 months; * Active peptic ulcer or upper gastrointestinal (GI) bleeding within the previous 6 months; * History of bleeding diathesis or coagulopathy or will refuse blood transfusions; * A known concurrent medical condition resulting in a life expectancy of less than 12 months; * Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy; * The subject is currently participating in another investigational device or drug study and has not completed the primary endpoint(s) follow-up phase of that study at least 30 days prior to enrollment in this trial; or interferes with the current trial endpoints; or the subject has previously been enrolled in the study; * The subject has a known medical condition that will cause them to be non-compliant with the study protocol or confound the data interpretation; * The target vessel has evidence of thrombus or other lesions having a \> 60% stenosis by visual estimate or on-line QCA; * Target vessel exhibiting multiple lesions with greater than 60% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line QCA; * The target vessel has evidence (visual or QCA) of excessive tortuosity (two or more 90° bends prior to the target lesion) or is severely calcified; OR * The target lesion is in an unprotected left main, involves a side branch vessel having a diameter of \> 2.0 mm or is at the aorto-ostial location