- 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-III) OR patients with documented silent ischemia;
- Treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries;
- Ostial lesions;
- Target vessel diameter of both lesions must be >=2.25mm and <=3.0mm in diameter (visual estimate);
- One target lesion must be at least 15 mm in length and the second lesion has to be at least 10 mm in length with no upper limit on either;
- Target lesion stenosis for both lesions is >50% and <100% (visual estimate).
- Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK >2 times normal within the preceding 72 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;
- Has unstable angina classified as Braunwald A I-II-III;
- Any of the lesions is an unprotected left main coronary disease with >=50% stenosis;
- Angiographic evidence of thrombus within target lesion;
- Heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated (applies to both lesions);
- Documented left ventricular ejection fraction <=25%;
8. Totally occluded vessel (TIMI 0 level) (applies to both lesions);
9. Prior stent within 10mm of target lesion (applies to both lesions).