The MASS COMM Post-Randomization Phase Cohort Study

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 Study, unless the patient has completed the 30-day follow-up for the Cohort Study.
• •Within 30 days prior to the index Cohort Study procedure, the subject has undergone a previous coronary interventional procedure of any kind. Note: This exclusion criterion does not apply to post-STEMI patients.
• •Stroke or transient ischemic attack within the prior 3 months.
• •Active peptic ulcer or upper GI bleeding within the prior 3 months.
• •Subject has active sepsis.
• •Unprotected left main coronary artery disease (stenosis greater than 50%).
• •Subject has evidence of a hemodynamically insignificant stenosis determined by FFR measurement (FFR greater than 0.8).
• •In the investigator's opinion, subject has a co-morbid condition(s) that could limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study.
• •Subject has normal or insignificant coronaries (i.e., coronary lesion(s) less than 50% stenosis).
• •Any target vessel has evidence of:
• •1. excessive thrombus (e.g., requires target vessel thrombectomy)
• •2. tortuosity (greater than 60 degree angle) that makes it unsuitable for proper stent delivery and deployment,
• •3. heavy calcification.
• •Any target lesion requires treatment with a device other than PTCA prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
• •Any lesion that is located in a saphenous vein graft, however, lesions located within the native vessel but accessed through the graft are eligible.
• •The target vessel is in a "last remaining" epicardial vessel (e.g., \>2 non-target epicardial vessels and the bypass grafts to these territories \[if present\] are totally occluded).