The MASS COMM Post-Randomization Phase Cohort Study

Study Overview
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Brief Summary
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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]).

Detailed Description
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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.

Official Title
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A Prospective, Multi-center, Non-Randomized, Single-arm, Open-label Study of Percutaneous Coronary Intervention in Community Hospitals Without Cardiac Surgery-On-Site

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: PCI


Participation Criteria
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Eligibility Criteria
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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: excessive thrombus (e.g., requires target vessel thrombectomy) tortuosity (greater than 60 degree angle) that makes it unsuitable for proper stent delivery and deployment, 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Non-SOS<br> | Procedure: PCI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Event (MACE) | MACE is a composite of all cause mortality, myocardial infarction (Q wave and non-Q wave), repeat coronary revascularization (of the target vessel or non-target vessel) by either percutaneous or coronary artery bypass graft (CABG) methods, or stroke, at 30-days. | 30-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-Cause Mortality | all-cause mortality through 30 days post-procedure | 30 days | 
| Stroke | Stroke through 30 days post-procedure | 30 days | 
| Revascularization | Repeat coronary revascularization including emergency or urgent revascularization through 30 days post-procedure | 30 days | 
| Major Vascular Complications | Major vascular complications, including access site complications and major bleeding events requiring transfusion,through 30 days post-procedure. | 30 days |