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OpenTrials
Completed

NCT Number: NCT02418156

A 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.

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Key information

Conditions

Peripheral Vascular Disease Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must be undergoing femoral arterial reconstruction with patch angioplasty closure
  • Surgeon intends to use CorMatrix ECM per FDA cleared Indications for Use
  • Subject possesses ability to provide informed consent
  • Subject expresses understanding and willingness to fulfill all expected requirements of protocol

Exclusion criteria

  • Known sensitivity to porcine material

Treatment and study plan

CorMatrix ECM for Vascular Repair

Device

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

Primary outcomes

  1. Device-Related Adverse Events

    Time frame: Up to 12 months follow-up

    Proportion of patients experiencing device related adverse events.

Sponsors and collaborators

Lead sponsor

Elutia Inc.

Industry

Registry information

Official study title

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

Acronym: PERFORM

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 16, 2015
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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