Ignite Creation Date:
2024-05-06 @ 1:01 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03918460
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2019-04-12
Brief Title:
ANEUFIX for Endoleak Type II Repair
Sponsor:
TripleMed BV
Organization:
TripleMed BV
Study Overview
Official Title:
Treatment of Type II Endoleak With ANEUFIX Assessment of Safety Performance and Clinical Benefit
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The study is non-randomized multicenter international safety performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR procedure more than 6 months ago
Detailed Description:
The investigational device is called ANEUFIX which is a product treating the endoleak by blockage of backflowing blood vessels ie 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 37C after injection into the AAA-sac close to the nidus
ANEUFIX is a polymer that cures rapidly 2-4 min at 37C after injection into the AAA-sac close to the nidus
Study Oversight
Has Oversight DMC:
None
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?:
None