De Novo Pilot Study, Lutonix Catheter in Conjunction With Bare Metal Stenting for Treatment of Coronary De Novo Lesions

Inclusion Criteria: * Male or non-pregnant/non-breast feeding Female ≥ 18 years of age. Women of childbearing potential must have a negative pregnancy test (within 7 days of the procedure); * Documented stable angina pectoris Canadian Cardiovascular Society Classification (CCSC) 1-4, unstable angina pectoris with documented ischemia (Braunwald I-II) or documented silent ischemia; * Left ventricular ejection fraction (LVEF) ≥ 25%; * Patient is an acceptable candidate for PTCA, stenting, and emergent coronary artery bypass grafting (CABG); * Patient is willing to provide informed consent and comply with follow-up visits and testing schedule; * Target lesion is a de novo lesion in a native coronary artery vessel; * Initial stenosis is ≥ 50% and \< 100% by visual estimate or quantitative coronary angiography (QCA); * Reference Vessel Diameter (RVD) is ≥ 2.5 and ≤ 3.25 prior to predilation; * Target lesion is ≤18mm in length and can be treated in its entirety by no more than 1 single Lutonix Catheter balloon and 1 single BMS; * Guidewire is able to cross lesion and be placed in distal vessel prior to enrollment; * Enrollment permitted after successful treatment of 1 non-study lesion in a single other non-study vessel (not in the same vascular territory as the study lesion). Successful treatment is defined as ≤ 30% residual stenosis with Thrombolysis in Myocardial Infarction (TIMI) Grade III flow and not evidence of dissection. Exclusion Criteria: * History of stroke within past 6 months; * History of myocardial infarction (MI) or thrombolysis within 72 hours of randomization; * Prior vascular brachytherapy; * Uncontrollable allergies to procedure medications, materials or contrast; * Angiographic evidence of thrombus or dissection within the target vessel; * Intervention of another coronary lesion ≤ 60 days before index procedure day or planned following index procedure; * Target lesion is planned to be treated with something other than PTCA and stent (i.e., cutting-balloon, atherectomy, vascular brachytherapy (VBT), etc.); * Target lesion is in the Left Main and has excessive calcification or tortuosity or involves bifurcation disease of vessel ≥ 2.5mm; * Known sensitivity or has received paclitaxel or other antimitogenic agent within 12 months prior to target vessel treatment; * Patient has any previous intervention (PTCA, stent, etc.) of the target coronary vessel; * Any medical condition, in the investigators opinion, that should preclude the patient from the study or patient has a life expectancy less than 24 months; * Known creatine kinase-MB (CKMB) \> 2x upper limit of normal (ULN) or positive Troponin; * Creatinine \> 2.0 mg/dl; * Leukocyte \< 3500/mL; * Platelet \< 100,000 mL or \> 750,000 mL; * Currently taking or must resume warfarin; * Patient is contraindicated for antiplatelet therapy or it will need to be withdrawn for a planned procedure; * The subject is currently participating in another investigational drug or device study.