the mass comm post-randomization phase cohort study

Conditions: Coronary Artery Disease

Summary: the primary objective of the post-randomization phase cohort study is to continue to assess the safety of non-emergency pci performed at hospitals without cardiac surgery on-site in patients with myocardial ischemia (other than st-segment elevation myocardial infarction \[stemi\]).

the mass comm post-randomization phase cohort study ("cohort study" is a prospective, multi-center, single-arm study of non-emergency pci performed at non-sos hospitals in patients with myocardial ischemia (other than stemi). the cohort study is designed to allow non-sos hospitals to continue to perform non-emergency pci after enrollment to the mass comm trial is completed and before the 30-day and 12-month results are available. specifically, all eligible subjects, after enrollment to the mass comm randomized controlled trial is completed and before the final results are available and a decision is reached by the ma-dph, will be consented and enrolled into this cohort study. subjects will be followed through 30 days post procedure.

Eligibility criteria:
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 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. angiographic exclusion criteria * 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).