A Randomized, Double-Blind, Controlled Study of the Safety and Performance of the NIRx™ Paclitaxel-Coated Conformer Coronary Stent

General Inclusion Criteria: * Patient \>= 18 years old. * Eligible for percutaneous transluminal coronary angioplasty (PTCA). * Patient (or legal guardian) understands the study requirements and the stent treatment procedure and provides written Informed Consent before any study-specific tests or procedures are performed. * Willing to comply with all specified follow-up evaluations. * Documented stable angina pectoris (Canadian Cardiovascular Society Classification \[CCS\] 1, 2, 3, or 4), unstable angina pectoris with documented ischemia (Braunwald Class IB - C, IIB - C, or IIIB - C), or documented silent ischemia. * Acceptable candidate for CABG. Angiographic Inclusion Criteria: * Target lesion is located within a native coronary vessel. * Target lesion is de novo (i.e., a coronary lesion not previously treated). * Target lesion diameter stenosis \>= 50% and \<= 99% (visual estimate or on-line QCA). * Target lesion \<= 12 mm in length (visual estimate or on-line QCA). * Target vessel \>= 3.0 mm and \<= 3.5 mm in diameter (visual estimate or on-line QCA). General Exclusion Criteria: * Known sensitivity to paclitaxel. * Patient has received paclitaxel or other anti-mitogenic agent within 12 months prior to planned enrollment in the study. * Patient has previous stent procedure with any drug-coated or drug-eluting stent device. * Patient has undergone any coronary intervention within 30 days prior to stent placement associated with this protocol. * Patient anticipates planned additional intervention (staged procedure) to any non-target coronary vessel within 45 days after the stent placement associated with this protocol. * MI within 72 hours of planned stent placement. * Left ventricular ejection fraction (LVEF) of \< 30%. * Stroke within the past 6 months. * Acute or chronic renal dysfunction (creatinine \>1.7 mg/mL or \>150 µmol/L). * Acetylsalicylic acid and/or clopidogrel and/or ticlopidine are contraindicated. * Leukopenia (leukocytes \<3.5 x 109/liter). * Thrombocytopenia (platelets \<100,000/mm3). * Active peptic ulcer or active gastrointestinal (GI) bleeding. * Known allergy to stainless steel. * Previously enrolled in the NIRx(TM) Coronary Stent Clinical Safety and Performance Study. * Currently enrolled in another investigational device or drug study and has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days prior to enrollment in this study. * Patient is lactating, has a positive pregnancy test within 7 days of planned stent placement, or intends to become pregnant during the study (only applies to female patients of child-bearing potential). * Life expectancy of less than 24 months because of other medical conditions. * Co-morbid condition(s) that could limit the patient's ability to participate in the study or comply with follow-up requirements or co-morbid condition(s) that could impact the scientific integrity of the study. Angiographic Exclusion Criteria: * Unprotected left main coronary artery disease (or obstruction greater than 50% in the left main coronary artery that is not protected by at least 1 non-obstructed bypass graft to the left anterior descending \[LAD\] or circumflex artery or a branch thereof). * Target lesion is in a previously stented segment. * Target vessel was treated with directional coronary atherectomy, laser, or transluminal extraction catheter prior to stent placement. * Target lesion is ostial in location (within 3 mm of vessel origin). * Target site of stent placement has side branches \>2.0 mm in diameter. * Target lesion is severely calcified (by visual estimate) * Target vessel has closed abruptly or is threatening closure. * Target lesion is located within or immediately distal to a \>60° bend in the vessel. * Target vessel has diffuse disease requiring more than one 15 mm stent for full lesion coverage. * Target lesion involves a bifurcation where a branch vessel greater than 2.0 mm in diameter originates (either stenosis of both main vessel and major branch or stenosis of just major branch). * Target lesion has excessive tortuosity unsuitable for stent delivery and deployment. * Target lesion is located within a saphenous vein bypass graft. * Target lesion is located in a vessel section supplied by distal graft.