OPTIMIZE IDE for the Treatment of ACS

Inclusion Criteria:

- 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 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;

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;