Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964348
Status:
WITHDRAWN
Last Update Posted:
2023-07-27
First Post:
2023-05-11
Brief Title:
REGISTRY for the Use of a Software for Automatic Detection of the Evolution of Aneurysmal Volume and Graft Migration After EVAR EndoVascular Aneurysm Repair
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
REGISTRY for the Use of a Software for Automatic Detection of the Evolution of Aneurysmal Volume and Graft Migration After EVAR EndoVascular Aneurysm Repair
Status:
WITHDRAWN
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the study was no longer of scientific interest and other publications rendered it obsolete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AI-EVAR-FOLLOW
Brief Summary:
The objective of this registry is to find and validate a correlation between morphological indicators such as volume sac evolution graft migration or length between anatomical landmarks with aneurysm rupture risk or complications such as endoleaks requiring re-intervention Secondary objectives are the validation of the reproducibility and accuracy of a dedicated fully automated software enabling Abdominal Aortic Aneurysm AAA segmentation to measure AAA diameter volume evolution and growth over time proximal and distal sealing zones analyze as well as device migration and integrity after EVAR on computed tomography angiography CTA This validation is in comparison with semi-automated analyse controlled by physician
Detailed Description:
None
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