The MASS COMM Post-Randomization Phase Cohort Study

Completed · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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 \[STEMI\]).

Key facts

Study ID

NCT02072421

Run by

Baim Institute for Clinical Research

People needed

2879

Starts

2011-10-01

Expected to finish

2013-10-01

Last updated by the study team

2015-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Good Samaritan Medical Center — Brockton, Massachusetts, United States
• Brockton Hospital — Brockton, Massachusetts, United States
• Metrowest Medical Center — Framingham, Massachusetts, United States
• Lawrence General Hospital — Lawrence, Massachusetts, United States
• Saints Memorial Medical Center — Lowell, Massachusetts, United States
• Lowell General Hospital — Lowell, Massachusetts, United States
• Melrose-Wakefield Hospital — Melrose, Massachusetts, United States
• Holy Family Hospital — Methuen, Massachusetts, United States
• Norwood Hospital — Norwood, Massachusetts, United States
• South Shore Hospital — Weymouth, Massachusetts, United States

Full record on ClinicalTrials.gov

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