NCT02072421

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,879 (actual)
• Sponsor: Baim Institute for Clinical Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	PCI

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2014-02-26
• Last updated: 2015-04-07
• Results posted: 2014-07-08

Locations

10 sites across 1 country: United States