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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

NCT02072421•Baim Institute for Clinical Research

View on ClinicalTrials.gov

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 \[STEMI\]).

Detailed Description

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

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.
+15 more criteria

Locations (10)

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

Key Dates

Start Date

October 1, 2011

Primary Completion Date

September 1, 2013

Completion Date

October 1, 2013

Last Updated

April 7, 2015

Enrollment

2,879

ACTUAL participants

Conditions

Coronary Artery Disease

Interventions

PCI

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 7, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The MASS COMM Post-Randomization Phase Cohort Study

Inclusion Criteria

Exclusion Criteria

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

"Erectile Function After PCI in MI and Non-MI Patients"

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