REGISTRY for the Use of a Software for Automatic Detection of the Evolution of Aneurysmal Volume and Graft Migration After EVAR (EndoVascular Aneurysm Repair)
- Conditions
- Aneurysm Aortic
- Interventions
- Procedure: CT-Scan
- Registration Number
- NCT05964348
- Lead Sponsor
- University Hospital, Bordeaux
- 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
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
-
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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient with infrarenal abdominal aortic aneurysms CT-Scan Patient with infrarenal abdominal aortic aneurysms treated with EVAR
- Primary Outcome Measures
Name Time Method Measurement of length between anatomical points evolution Month 12 Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.
Collection of the different events and complications of the aneurysm post EVAR Month 12 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
Measurement of aneurysm sac volume evolution Month 12 Measurement of the aneurysm sac volume in cc on the CT scans available
Measurement of graft migration Month 12 Measurement of the graft migration if existing on the CT scans available
Measurement of morphological neck characteristics Month 12 Measurement of the morphological neck characteristics in mm on the CT scans available
- Secondary Outcome Measures
Name Time Method Repeatability between measures (intra observer variability) Month 12 Descriptive analysis of the different measurements by overlaps metric analysis
Average time for segmentation (sec) Month 12 The time for segmentation by junior/senior surgeon and software is recorded
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation Month 12 Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis
Average time for segmentation in comparison with semi-automated segmentation Month 12 Description of the average time between the different techniques.
Total Volume measurement of AAA Month 12 Description of the volume measurement of the AAA with the following items:
* Volume circulating
* Intraluminal thrombus volume
* Calcification volume
Trial Locations
- Locations (1)
Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux
🇫🇷Bordeaux cedex, France