The MASS COMM Post-Randomization Phase Cohort Study
Coronary Artery Disease
About this trial
This is an interventional health services research trial for Coronary Artery Disease
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:
- 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).
Sites / Locations
- Good Samaritan Medical Center
- Brockton Hospital
- Metrowest Medical Center
- Lawrence General Hospital
- Saints Memorial Medical Center
- Lowell General Hospital
- Melrose-Wakefield Hospital
- Holy Family Hospital
- Norwood Hospital
- South Shore Hospital
Arms of the Study
Arm 1
Other
Non-SOS