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NCT02418156 Clinical Trial

A Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction

Peripheral Vascular Disease Clinical Trial

— PERFORM  

Official title:
A Post Market Observational Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02418156
Other study ID # 14-PR-1120
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2015
Est. completion date March 2018

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

Clinical Trial Summary

To gather information on the use of CorMatrix ECM for Vascular Repair in the reconstruction of the femoral artery.

Description:

OBJECTIVE The objective of the study is to actively gather additional information on the use of CorMatrix ECM for vascular repair in the reconstruction of the femoral artery. The CorMatrix ECM for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Subjects must be undergoing femoral arterial reconstruction with patch angioplasty closure 2. Surgeon intends to use CorMatrix ECM per FDA cleared Indications for Use 3. Subject possesses ability to provide informed consent 4. Subject expresses understanding and willingness to fulfill all expected requirements of protocol Exclusion Criteria: 1. Known sensitivity to porcine material

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CorMatrix ECM for Vascular Repair
Standard femoral arterial interventional procedure using CorMatrix ECM for vascular repair.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Aziyo Biologics, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Device-Related Adverse Events Proportion of patients experiencing device related adverse events. Up to 12 months follow-up
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