REGISTRY on the Implementation of Artificial Intelligence in the Automatic Analysis of Vascular Network Segmentation

NCT06451315 | Recruiting

• 1 other identifier: CHUBX 2023/77
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (15)

• 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

Study Arms (1)

Abdominal Aortic Aneurysm (AAA) treated with EndoVascular Aneurysm Repair (EVAR)

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

Procedure: Analyze CTscans pre-operatively by Nurea System; Procedure: Analyze CTscans pre-operatively by hospital practitioner

Interventions

Analyze CTscans pre-operatively by Nurea System PROCEDURE

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

Abdominal Aortic Aneurysm (AAA) treated with EndoVascular Aneurysm Repair (EVAR)

Analyze CTscans pre-operatively by hospital practitioner PROCEDURE

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

Abdominal Aortic Aneurysm (AAA) treated with EndoVascular Aneurysm Repair (EVAR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient came to the vascular surgery unit for his post-operative follow-up visit who have had surgery for Abdominal Aortic Aneurysm

You may qualify if:

• Male or female ≥18 years of age
• 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.
• Available for set-up and proper implementation of follow-up visits (standard of care) throughout the duration of the registry

You may not qualify if:

• Advancing Alzheimer's disease or socially dependent patient
• Opposition to the use of their data for this research
• Life expectancy supposed to be inferior to 2 years
• Pregnant woman

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Nurea: collaborator

Study Sites (1)

Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux

Bordeaux, 33076, France

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Eric DUCASSE, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric DUCASSE, MD, PhD

CONTACT

+33 5 56 79 55 25; eric.ducasse@chu-bordeaux.fr

Olivier DELORME

CONTACT

+ 33 5 57 65 60 05; olivier.delorme@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 11, 2024
• Study Start: January 30, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-05

Locations

FR (1)