CorMatrix ECM for Carotid Repair Following Endarterectomy Registry

Aziyo Biologics

Status

Completed

Conditions

Carotid Stenosis

Treatments

Device: CorMatrix ECM for Carotid Repair

Study type

Observational

Funder types

Industry

Identifiers

NCT01569594

11-PR-1021

Details and patient eligibility

About

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

Full description

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.

Enrollment

230 patients

Sex

All

Volunteers

No Healthy Volunteers

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