CorMatrix ECM Study: To Identify Inflammatory Markers Following CABG With/Without ECM
NCT01535807 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2022-11-07
Summary
The objective of this study is to identify proteomic inflammatory biomarkers to determine if there are differences in the biomarkers in patients who are treated using the CorMatrix ECM implant to close the pericardium and the patients whose pericardium is left open (the current standard of care).
Conditions
Interventions
- DEVICE
-
CorMatrix extra cellular matrix (ECM)
* Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique. * No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.
Sponsors & Collaborators
-
CorMatrix Cardiovascular, Inc.
collaborator INDUSTRY -
Inova Health Care Services
lead OTHER
Principal Investigators
-
Niv Ad, MD · Inova Health Systems
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2013-02-28
- Completion
- 2016-06-30
Countries
- United States
Study Locations
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