CorMatrix ECM for Carotid Repair Following Endarterectomy Registry

July 19, 2023 updated by: Aziyo Biologics, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Cardio-Thoracic Surgeons, P.C. Trinity
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Vascular Surgical Associates P.C.
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Cardiac Surgery Associates
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St Luke's Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Cardiovascular Surgery Clinic, PLLC
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • UVA Heart and Vascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Up to 230 subjects may be enrolled from up to ten U.S. clinical sites

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Carotid Endarterectomy Subjects
Subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair
Device: CorMatrix ECM for Carotid Repair
Subjects must be undergoing carotid endarterectomy with patch angioplasty closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Carotid Procedure and Device Related Adverse Events to Determine Device Performance
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aziyo Biologics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

March 30, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimated)

April 3, 2012

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-PR-1021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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