• Final residual diameter stenosis < 50% by Quantatative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion
  

• Composite of MACE defined as death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR) at discharge and 30 days post-procedure. [ Time Frame: Discharge and 30 days post-procedure ]
  

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;