Overview

This trial is active, not recruiting.

Condition carotid stenosis
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

Summary

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

Study Design

Observational model case-only
Time perspective prospective
Arm
cormatrix ecm for carotid repair
Subjects must be undergoing carotid endarterectomy with patch angioplasty closure

Primary Outcomes

Measure
Carotid procedure and device related adverse events to determine device performance
time frame: 2 years

Eligibility Criteria

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.

Additional Information

Official title CorMatrix® ECM® for Carotid Repair Following Endarterectomy Registry
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by CorMatrix Cardiovascular, Inc..