CorMatrix ECM for Carotid Repair Following Endarterectomy Registry
This trial is active, not recruiting.
|Treatment||cormatrix ecm for carotid repair|
|Sponsor||CorMatrix Cardiovascular, Inc.|
|Start date||April 2012|
|End date||March 2016|
|Trial size||230 participants|
|Trial identifier||NCT01569594, 11-PR-1021|
The objective of this registry is to capture and assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair per its FDA cleared Indications for Use. This registry provides an ongoing post-market surveillance mechanism to document clinical outcomes on the use of the CorMatrix ECM for Carotid Repair.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Birmingham, AL||Cardio-Thoracic Surgeons, P.C. Trinity||no longer recruiting|
|Marietta, GA||Vascular Surgical Associates P.C.||no longer recruiting|
|Indianapolis, IN||Cardiac Surgery Associates||no longer recruiting|
|Kansas City, MO||St Luke's Hospital||no longer recruiting|
|Memphis, TN||Cardiovascular Surgery Clinic, PLLC||no longer recruiting|
|Charlottesville, VA||UVA Heart and Vascular Center||no longer recruiting|
Carotid procedure and device related adverse events to determine device performance
time frame: 2 years
Male or female participants of any age.
Inclusion Criteria: - Subjects must be undergoing carotid endarterectomy with patch angioplasty closure. - Subject's operative surgeon intends to use CorMatrix ECM as the patch material for closure of the carotid artery per its FDA cleared Indications for Use. - The subject must possess the ability to provide written Informed Consent. - The subject must express an understanding and willingness to fulfill all of the expected requirements of this clinical protocol. Exclusion Criteria: - Subjects with a known sensitivity to porcine material.
|Official title||CorMatrix® ECM® for Carotid Repair Following Endarterectomy Registry|
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