NCT06451315|Unknown
REGISTRY on the Implementation of Artificial Intelligence in the Automatic Analysis of Vascular Network Segmentation
IAVASC
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IAVASC
Sponsor study identifier
observational
250
1 country
1
Study Start
January 30, 2024
Actual (reported)Primary Completion
July 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The team hypothesizes that fully automatic analysis of AAA could provide increased performance (decreased duration of segmentation with increased reproducibility and decreased inter and intraobserver variability) to detect aortic aneurysmal sac enlargement (volumes and diameters) and predict the risk of complications during the procedure and during follow-up (MAE, MACE, MALE, Stroke) compared to standard methods of measurement relying on approximate maximum sac diameter.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 30, 2024
Actual (reported)May 31, 2024
Actual (reported)June 11, 2024
Actual (reported)July 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
global volume measure of the aneurysm
global volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
6 months before surgery
global volume measure of the aneurysm
global volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Day 3
global volume measure of the aneurysm
global volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Month 3
global volume measure of the aneurysm
global volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Month 6
global volume measure of the aneurysm
global volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Month 12
lumen volume measure of the aneurysm
6 months before surgery
lumen volume measure of the aneurysm
Day 3
lumen volume measure of the aneurysm
Month 3
lumen volume measure of the aneurysm
Month 6
lumen volume measure of the aneurysm
Month 12
Male or female ≥18 years of age with AAA treated with EVAR between ≥50mm or ≥5mm increase in 6 months. The subject is legally competent, has been informed of the nature, the scope, and the relevance of the study and has not manifested an opposition to participate. He is available for set-up and proper implementation of follow-up visits (standard of care) throughout the duration of the registry
CTscans will be analyzed pre-operatively (6 months before intervention) and post-operatively with an early control scan (up to one-month post-EVAR), compared to a 3, 6 and 12-month control scan by system develop by Nurea
CTscans will be analyzed pre-operatively (6 months before intervention) and post-operatively with an early control scan (up to one-month post-EVAR), compared to a 3, 6 and 12-month control scan by an hospital practitioner
The patient came to the vascular surgery unit for his post-operative follow-up visit who have had surgery for Abdominal Aortic Aneurysm
Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux
Bordeaux, 33076, France
Eric DUCASSE, MD, PhD
University Hospital, Bordeaux
First Submitted
May 31, 2024
First Posted
June 11, 2024
Study Start
January 30, 2024
Actual (reported)Primary Completion
July 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
July 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 13, 2024
Record last verified: 2024-05
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Source: ClinicalTrials.gov.
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