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

July 19, 2023 updated by: Aziyo Biologics, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

38

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients presenting for femoral arterial reconstruction with patch angioplasty.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single Arm
Subjects undergoing femoral arterial reconstruction using CorMatrix ECM for vascular repair.
Device: CorMatrix ECM for Vascular Repair
Standard femoral arterial interventional procedure using CorMatrix ECM for vascular repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device-Related Adverse Events
Time Frame: Up to 12 months follow-up
Proportion of patients experiencing device related adverse events.
Up to 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aziyo Biologics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

April 9, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimated)

April 16, 2015

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-PR-1120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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