The MASS COMM Post-Randomization Phase Cohort Study

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

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.

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).