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

Elutia Inc.38 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Peripheral Vascular Disease

Interventions

CorMatrix ECM for Vascular RepairDEVICE

Standard femoral arterial interventional procedure using CorMatrix ECM for vascular repair.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Device-Related Adverse Events

Proportion of patients experiencing device related adverse events.

Time frame: Up to 12 months follow-up

Data from ClinicalTrials.gov

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