Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-03-11 @ 9:10 PM
Study NCT ID:
NCT04307992
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2020-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AneuFix - Prophylactic Sac Filling
Sponsor:
TripleMed B.V.
Organization:
Study Overview
Official Title:
Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.
Detailed Description:
The investigational device is called ANEUFIX, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the endoleak void and nidus of feeding artery and exit of existing draining arteries.
ANEUFIX is a polymer that cures rapidly (2-4 min at 37°C) after injection into the AAA-sac close to the nidus.
ANEUFIX is a polymer that cures rapidly (2-4 min at 37°C) after injection into the AAA-sac close to the nidus.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: