A Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction
Completed
- Conditions
- Peripheral Vascular Disease
- Registration Number
- NCT02418156
- Lead Sponsor
- Aziyo Biologics, Inc.
- Brief Summary
To gather information on the use of CorMatrix ECM for Vascular Repair in the reconstruction of the femoral artery.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Device-Related Adverse Events Up to 12 months follow-up Proportion of patients experiencing device related adverse events.
- Secondary Outcome Measures
Name Time Method