N/A
N=38
A Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction
Peripheral Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT02418156 ↗Enrolled (actual)
38
Serious AEs
36.8%
Results posted
Feb 2020
Primary outcome: Primary: Device-Related Adverse Events — 0 Proportion of Participants that Experien
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CorMatrix ECM for Vascular Repair (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Elutia Inc.
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device-Related Adverse Events |
— | — |
Summary
To gather information on the use of CorMatrix ECM for Vascular Repair in the reconstruction of the femoral artery.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02418156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.