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

Aziyo Biologics

Status: Completed

Conditions: Peripheral Vascular Disease

Treatments: Device: CorMatrix ECM for Vascular Repair

Study type: Observational

Funder types: Industry

Identifiers

NCT02418156

14-PR-1120

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

38 participants in 1 patient group

Single Arm

Description:

Subjects undergoing femoral arterial reconstruction using CorMatrix ECM for vascular repair.

Treatment:

Device: CorMatrix ECM for Vascular Repair