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

Study results available
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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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01535807 on ClinicalTrials.gov