NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions

Inclusion Criteria: 1. Male or non-pregnant female patients 18 years of age 2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia; 3. Treatment of a single de novo target lesion in a major native coronary artery; 4. Target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate); 5. Target lesion is 30mm in length (visual estimate); 6. Target lesion stenosis is \> 50% and \< 100% (visual estimate); Exclusion Criteria: 1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \> 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment; 2. Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina; 3. Significant (\> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff; 4. Documented Left ventricular ejection fraction 25%; 5. Totally occluded vessel (TIMI 0 level); 6. Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;