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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Peripheral Vascular Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Arm

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

CorMatrix ECM for Vascular Repair

Intervention Type DEVICE

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

Interventions

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CorMatrix ECM for Vascular Repair

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

Intervention Type DEVICE

Eligibility Criteria

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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