Ignite Creation Date:
2024-05-06 @ 7:10 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02487290
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2015-06-29
Brief Title:
ANEUFIX for Endoleaks Type II
Sponsor:
TripleMed BV
Organization:
TripleMed BV
Study Overview
Official Title:
Feasibility Study of Treatment Type II Endoleaks With ACP-T5 a Novel Approach
Status:
COMPLETED
Status Verified Date:
2021-02
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:
ACP-T5
Brief Summary:
The study is a non-randomized multi-center safety and feasibility trial of Aneufix ACP-T5 to treat patients with Isolated type II endoleak in the presence of a non-shrinking AAA sac following an EVAR procedure
Detailed Description:
The investigational device is called Aneufix more specifically the model ACP-T5 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
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