The MASS COMM Post-Randomization Phase Cohort Study

Inclusion Criteria

Candidates for this study must meet ALL of the following criteria:

• Subject is at least 18 years old.
• Subject requires single- or multi-vessel percutaneous coronary intervention (PCI) of de novo or restenotic target lesion (including in-stent restenotic lesions). N.B. staged procedure will not be considered to meet the endpoint component of repeat revascularization if either of the following pre-catheterization procedure qualifying clinical laboratory values are met:
• eGFR is less than 60 ml/min or
• creatinine is greater than 1.5 mg/dl
• Subject's lesion(s) is (are) amenable to stent treatment with currently available FDA-approved bare metal or drug eluting stents.
• Subject is an acceptable candidate for non-emergency, urgent or emergency CABG.
• Subject has clinical evidence of ischemic heart disease in terms of a positive functional study, or documented symptoms.
• Documented stable angina pectoris [Canadian Cardiovascular Society Classification (CCS) 1, 2, 3, or 4], unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), non-ST segment elevation myocardial infarction, or documented silent ischemia.
• Subject and the treating physician agree that the subject will comply with all follow-up evaluations.
• Subject has been informed of the nature and purpose of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.

Angiographic Inclusion Criteria

• The target lesion(s) is (are) de novo or restenotic (including in-stent restenotic) native coronary artery lesion(s) with greater or equal to 50 and less than 100% stenosis (visual estimate), or the target lesion is an acute (less than 1 month) total occlusion as evidenced by clinical symptoms.
• If Fractional Flow Reserve (FFR) is measured, target lesion(s) has (have) evidence of a hemodynamically significant stenosis determined by FFR measurement (FFR less than or equal to 0.8).
• Target lesions(s) is (are) located in an infarct (if not treated with primary PCI) or non-infarct-related artery with a 70% or greater stenosis (by visual estimate) greater than 72 hours following the STEMI.

Lesions treated with PCI greater than 72 hours following STEMI would be subject to the same protocol inclusion/exclusion criteria listed above and below with the exception that a target lesion of 70% or greater stenosis may be treated with or without symptoms or abnormal stress test).

Exclusion Criteria

Subjects will be excluded from participation in the Cohort Study (and non-emergency PCI may not be performed in these patients at the non-SOS site) if ANY of the following conditions apply:

• The patient is pregnant or breastfeeding.
• Evidence of ST segment elevation myocardial infarction within 72 hours of the intended treatment on infarct related or non-infarct related artery.
• Cardiogenic shock on presentation or during current hospitalization.
• Left ventricular ejection fraction less than 20%.
• Known allergies to: aspirin, clopidogrel (Plavix), prasugrel (Effient), and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent (which cannot be adequately premedicated).
• A platelet count less than 75, 000 cells/mm3 or greater than 700,000 cells/mm3 or a WBC less than 3,000 cells/mm3.
• Acute or chronic renal dysfunction (creatinine less than 2.5 mg/dl or less than 150µmol/L).
• Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).
• Prior participation in the MASS-COMM Trial, unless the patient has completed the 12-month follow-up for the Trial, and/or prior participation in the Cohort S