18 years and older

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 native coronary artery lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment

Target vessel diameter at the lesion site is >=2.50mm and <=3.0mm in diameter (visual estimate)

Target lesion is >=15mm and <=32mm in length (visual estimate)

Target lesion stenosis 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 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment

Has unstable angina classified as Braunwald III B or C and A I-II-III, or is having a peri infarction

Unprotected left main coronary disease with >=50% stenosis

Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff

Have an ostial target lesion

Angiographic evidence of thrombus within target lesion

Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated

Documented left ventricular ejection fraction <=25%

Single vessel disease

Double vessel disease

Triple vessel disease

Coronary artery disease (CAD)

Vessel lumen diameter

Stenotic lesion length

Stenosis

Acute myocardial infarction

CK

CK-MB

OPERATIONS / PROCEDURES

Coronary arteriography

Thrombus

Calcification