Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2026-03-07 @ 2:28 PM
Study NCT ID:
NCT02418156
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2015-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction
Sponsor:
Elutia Inc.
Organization:
Study Overview
Official Title:
A Post Market Observational Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERFORM
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: