REGISTRY for the Use of a Software for Automatic Detection of the Evolution of Aneurysmal Volume and Graft Migration After EVAR (EndoVascular Aneurysm Repair) (AI-EVAR-FOLLOW)

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.

Study Overview

• Status: Withdrawn
• Conditions: Aneurysm Aortic
• Intervention / Treatment: Procedure: CT-Scan

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Bordeaux cedex, France, 33076
    • Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Male or female ≥18 years of age with an Infra-renal Abdominal Aortic Aneurysm treated with endovascular treatment, ≥50mm, or ≥5mm increase in 6 months or surviving Ruptured AAA

Description

Inclusion Criteria:

• Male or female ≥18 years of age

• Infra-renal Abdominal Aortic Aneurysm (AAA) treated with EVAR

  • ≥50mm
  • or ≥5mm increase in 6 months
  • or surviving Ruptured AAA
• legal capacity to make own decisions, informed of the nature of the registry, has signed non opposition form available for set-up and proper implementation of follow-up visits throughout the duration of the registry

Exclusion Criteria:

• 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 female

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with infrarenal abdominal aortic aneurysms; Patient with infrarenal abdominal aortic aneurysms treated with EVAR	Procedure: CT-Scan; semi-automated analyse by anatomical landmarks with a dedicated fully automated software

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of the different events and complications of the aneurysm post EVAR	Collection of the different events and complication occurred after the EVAR (post-operative (up to one month), 3, 6 and 12 months). The collection will be use to correlate with the measurement of the morphological indicators collected at the different time frame of the study	Month 1
Collection of the different events and complications of the aneurysm post EVAR	Collection of the different events and complication occurred after the EVAR (post-operative (up to one month), 3, 6 and 12 months). The collection will be use to correlate with the measurement of the morphological indicators collected at the different time frame of the study	Month 3
Collection of the different events and complications of the aneurysm post EVAR	Collection of the different events and complication occurred after the EVAR (post-operative (up to one month), 3, 6 and 12 months). The collection will be use to correlate with the measurement of the morphological indicators collected at the different time frame of the study	Month 6
Collection of the different events and complications of the aneurysm post EVAR	Collection of the different events and complication occurred after the EVAR (post-operative (up to one month), 3, 6 and 12 months). The collection will be use to correlate with the measurement of the morphological indicators collected at the different time frame of the study	Month 12
Measurement of aneurysm sac volume evolution	Measurement of the aneurysm sac volume in cc on the CT scans available	Month 1
Measurement of aneurysm sac volume evolution	Measurement of the aneurysm sac volume in cc on the CT scans available	Month 3
Measurement of aneurysm sac volume evolution	Measurement of the aneurysm sac volume in cc on the CT scans available	Month 6
Measurement of aneurysm sac volume evolution	Measurement of the aneurysm sac volume in cc on the CT scans available	Month 12
Measurement of morphological neck characteristics	Measurement of the morphological neck characteristics in mm on the CT scans available	Month 6 before intervention
Measurement of morphological neck characteristics	Measurement of the morphological neck characteristics in mm on the CT scans available	Month 1
Measurement of morphological neck characteristics	Measurement of the morphological neck characteristics in mm on the CT scans available	Month 3
Measurement of morphological neck characteristics	Measurement of the morphological neck characteristics in mm on the CT scans available	Month 6
Measurement of morphological neck characteristics	Measurement of the morphological neck characteristics in mm on the CT scans available	Month 12
Measurement of graft migration	Measurement of the graft migration if existing on the CT scans available	6 months before intervention
Measurement of graft migration	Measurement of the graft migration if existing on the CT scans available	Month 1
Measurement of graft migration	Measurement of the graft migration if existing on the CT scans available	Month 3
Measurement of graft migration	Measurement of the graft migration if existing on the CT scans available	Month 6
Measurement of graft migration	Measurement of the graft migration if existing on the CT scans available	Month 12
Measurement of length between anatomical points evolution	Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.	6 months before intervention
Measurement of length between anatomical points evolution	Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.	Month 1
Measurement of length between anatomical points evolution	Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.	Month 3
Measurement of length between anatomical points evolution	Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.	Month 6
Measurement of length between anatomical points evolution	Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation	Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis	Month
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation	Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis	6 months before intervention
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation	Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis	Month 1
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation	Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis	Month 3
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation	Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis	Month 6
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation	Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis	Month 12
Repeatability between measures (intra observer variability)	Descriptive analysis of the different measurements by overlaps metric analysis	6 months before intervention
Repeatability between measures (intra observer variability)	Descriptive analysis of the different measurements by overlaps metric analysis	Month 1
Repeatability between measures (intra observer variability)	Descriptive analysis of the different measurements by overlaps metric analysis	Month 3
Repeatability between measures (intra observer variability)	Descriptive analysis of the different measurements by overlaps metric analysis	Month 6
Repeatability between measures (intra observer variability)	Descriptive analysis of the different measurements by overlaps metric analysis	Month 12
Average time for segmentation (sec)	The time for segmentation by junior/senior surgeon and software is recorded	6 months before intervention
Average time for segmentation (sec)	The time for segmentation by junior/senior surgeon and software is recorded	Month 1
Average time for segmentation (sec)	The time for segmentation by junior/senior surgeon and software is recorded	Month 3
Average time for segmentation (sec)	The time for segmentation by junior/senior surgeon and software is recorded	Month 6
Average time for segmentation (sec)	The time for segmentation by junior/senior surgeon and software is recorded	Month 12
Average time for segmentation in comparison with semi-automated segmentation	Description of the average time between the different techniques.	6 months before intervention
Average time for segmentation in comparison with semi-automated segmentation	Description of the average time between the different techniques.	Month 1
Average time for segmentation in comparison with semi-automated segmentation	Description of the average time between the different techniques.	Month 3
Average time for segmentation in comparison with semi-automated segmentation	Description of the average time between the different techniques.	Month 6
Average time for segmentation in comparison with semi-automated segmentation	Description of the average time between the different techniques.	Month 12
Total Volume measurement of AAA	Description of the volume measurement of the AAA with the following items: Volume circulating; Intraluminal thrombus volume; Calcification volume	6 months before intervention
Total Volume measurement of AAA	Description of the volume measurement of the AAA with the following items: Volume circulating; Intraluminal thrombus volume; Calcification volume	Month 1
Total Volume measurement of AAA	Description of the volume measurement of the AAA with the following items: Volume circulating; Intraluminal thrombus volume; Calcification volume	Month 3
Total Volume measurement of AAA	Description of the volume measurement of the AAA with the following items: Volume circulating; Intraluminal thrombus volume; Calcification volume	Month 6
Total Volume measurement of AAA	Description of the volume measurement of the AAA with the following items: Volume circulating; Intraluminal thrombus volume; Calcification volume	Month 12

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Nurea
• Investigators: Principal Investigator: Eric DUCASSE, MD, PhD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2023
• Primary Completion (Estimated): August 31, 2023
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Software; CT scan; Abdominal Aortic Aneurysm; Semi-automated analyses
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: CHUBX 2022/66

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No