CorMatrix ECM for Carotid Repair Following Endarterectomy Registry
CorMatrix® ECM® for Carotid Repair Following Endarterectomy Registry
1 other identifier
observational
230
1 country
6
Brief Summary
Assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedFirst Posted
Study publicly available on registry
April 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2016
CompletedResults Posted
Study results publicly available
February 24, 2020
CompletedJuly 21, 2023
July 1, 2023
4.8 years
March 30, 2012
January 31, 2020
July 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Carotid Procedure and Device Related Adverse Events to Determine Device Performance
2 years
Study Arms (1)
Carotid Endarterectomy Subjects
Subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair
Interventions
Subjects must be undergoing carotid endarterectomy with patch angioplasty closure
Eligibility Criteria
Up to 230 subjects may be enrolled from up to ten U.S. clinical sites
You may qualify if:
- 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.
You may not qualify if:
- Subjects with a known sensitivity to porcine material.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elutia Inc.lead
Study Sites (6)
Cardio-Thoracic Surgeons, P.C. Trinity
Birmingham, Alabama, 35243, United States
Vascular Surgical Associates P.C.
Marietta, Georgia, 30060, United States
Cardiac Surgery Associates
Indianapolis, Indiana, 46237, United States
St Luke's Hospital
Kansas City, Missouri, 64111, United States
Cardiovascular Surgery Clinic, PLLC
Memphis, Tennessee, 38120, United States
UVA Heart and Vascular Center
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Director
- Organization
- Aziyo Biolgics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2012
First Posted
April 3, 2012
Study Start
April 1, 2012
Primary Completion
December 31, 2016
Study Completion
December 31, 2016
Last Updated
July 21, 2023
Results First Posted
February 24, 2020
Record last verified: 2023-07