ReZolve2 Clinical Investigation

Primary Inclusion Criteria: * Patient has evidence of myocardial ischemia or a positive functional study * Patient has a normal CK-MB * Target lesion has a visually estimated stenosis of ≥50% and \<100% * Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.75mm and ≤ 3.3mm * Target lesion length must be ≤ 14mm Primary Exclusion Criteria: * Patient has experienced a myocardial infarction (CK-MB or Troponin \> 5 X ULN) within 72 hours of the procedure * Patient has a left ventricular ejection fraction \< 30% * Patient has unprotected lest main coronary disease with ≥50% stenosis * The target vessel is totally occluded (TIMI Flow 0 or 1) * Target lesion involves a bifurcation (a lesion with a side branch ≥ 2.0 mm in diameter containing a ≥ 50% stenosis). * Target lesion is located within a bypass graft * Target lesion has possible or definite thrombus