CorMatrix ECM for Carotid Repair Following Endarterectomy Registry

Carotid Stenosis Clinical Trial

Official title:

CorMatrix® ECM® for Carotid Repair Following Endarterectomy Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569594
• Other study ID #: 11-PR-1021
• Status: Completed
• Start date: April 2012
• Est. completion date: December 31, 2016

Study information

• Verified date: July 2023
• Source: Aziyo Biologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Stenosis

Intervention

Device:
• CorMatrix ECM for Carotid Repair
Subjects must be undergoing carotid endarterectomy with patch angioplasty closure

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Aziyo Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotid Procedure and Device Related Adverse Events to Determine Device Performance		2 years