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COMPLETEDNCT01569594

CorMatrix ECM for Carotid Repair Following Endarterectomy Registry

Assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair.

Lead sponsor: Elutia Inc.•6 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Elutia Inc.

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.

Age

All ages

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 21, 2023Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment230

Start dateApr 2012

Last updatedJul 21, 2023

Condition

Carotid Stenosis

Locations shown

Cardio-Thoracic Surgeons, P.C. Trinity

Birmingham, Alabama

Vascular Surgical Associates P.C.

Marietta, Georgia

Cardiac Surgery Associates

Indianapolis, Indiana

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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: July 21, 2023Data synced to Clareo: May 3, 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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