OPTIMIZE IDE for the Treatment of ACS

Exclusion Criteria

• •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;
• •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;