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

Inclusion criteria

• Male or non-pregnant female patients 18 years of age
• 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;
• Treatment of a single de novo target lesion in a major native coronary artery;
• Target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate);
• Target lesion is 30mm in length (visual estimate);
• Target lesion stenosis is > 50% and < 100% (visual estimate);

Exclusion criteria

• 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;
• Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction angina;
• Significant (> 50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
• Documented Left ventricular ejection fraction 25%;
• Totally occluded vessel (TIMI 0 level);
• Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;