Einstein Montefiore

• Subject is an eligible candidate for percutaneous coronary intervention (PCI); - Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia; - Subject is an acceptable candidate for coronary artery bypass grafting (CABG); - Subject has up to 3 de novo target lesions in up to 2 native coronary artery vessels, with no more than 2 lesions in a single vessel, each meeting the angiographic criteria and none of the

. - Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.25 mm and ≤ 4.00 mm; Exclusion Criteria: - The subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina; - The subject's target lesion(s) is located in the left main artery; - The subject's target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate; - The subject's target lesion(s) is located within a saphenous vein graft or arterial graft; - The subject's target lesion(s) will be accessed via a saphenous vein graft or arterial graft;