Clinical trial NCT05964348: REGISTRY for the Use of a Software for Automatic Detection of the Evolution of Aneurysmal Volume and Graft Migration After EVAR (EndoVascular Aneurysm Repair)
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)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Aneurysm Aortic
Keywords: Abdominal Aortic Aneurysm
CT scan
Semi-automated analyses
Software
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Nurea
First posted: 2023-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Collection of the different events and complications of the aneurysm post EVAR
timeFrame: Month 1
measure: Collection of the different events and complications of the aneurysm post EVAR
timeFrame: Month 3
measure: Collection of the different events and complications of the aneurysm post EVAR
timeFrame: Month 6
measure: Collection of the different events and complications of the aneurysm post EVAR
timeFrame: Month 12
measure: Measurement of aneurysm sac volume evolution
timeFrame: Month 1
measure: Measurement of aneurysm sac volume evolution
timeFrame: Month 3
measure: Measurement of aneurysm sac volume evolution
timeFrame: Month 6
measure: Measurement of aneurysm sac volume evolution
timeFrame: Month 12
measure: Measurement of morphological neck characteristics
timeFrame: Month 6 before intervention
measure: Measurement of morphological neck characteristics
timeFrame: Month 1
measure: Measurement of morphological neck characteristics
timeFrame: Month 3
measure: Measurement of morphological neck characteristics
timeFrame: Month 6
measure: Measurement of morphological neck characteristics
timeFrame: Month 12
measure: Measurement of graft migration
timeFrame: 6 months before intervention
measure: Measurement of graft migration
timeFrame: Month 1
measure: Measurement of graft migration
timeFrame: Month 3
measure: Measurement of graft migration
timeFrame: Month 6
measure: Measurement of graft migration
timeFrame: Month 12
measure: Measurement of length between anatomical points evolution
timeFrame: 6 months before intervention
measure: Measurement of length between anatomical points evolution
timeFrame: Month 1
measure: Measurement of length between anatomical points evolution
timeFrame: Month 3
measure: Measurement of length between anatomical points evolution
timeFrame: Month 6
measure: Measurement of length between anatomical points evolution
timeFrame: Month 12
Secondary outcomes:
measure: Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
timeFrame: Month
measure: Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
timeFrame: 6 months before intervention
measure: Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
timeFrame: Month 1
measure: Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
timeFrame: Month 3
measure: Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
timeFrame: Month 6
measure: Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
timeFrame: Month 12
measure: Repeatability between measures (intra observer variability)
timeFrame: 6 months before intervention
measure: Repeatability between measures (intra observer variability)
timeFrame: Month 1
measure: Repeatability between measures (intra observer variability)
timeFrame: Month 3
measure: Repeatability between measures (intra observer variability)
timeFrame: Month 6
measure: Repeatability between measures (intra observer variability)
timeFrame: Month 12
measure: Average time for segmentation (sec)
timeFrame: 6 months before intervention
measure: Average time for segmentation (sec)
timeFrame: Month 1
measure: Average time for segmentation (sec)
timeFrame: Month 3
measure: Average time for segmentation (sec)
timeFrame: Month 6
measure: Average time for segmentation (sec)
timeFrame: Month 12
measure: Average time for segmentation in comparison with semi-automated segmentation
timeFrame: 6 months before intervention
measure: Average time for segmentation in comparison with semi-automated segmentation
timeFrame: Month 1
measure: Average time for segmentation in comparison with semi-automated segmentation
timeFrame: Month 3
measure: Average time for segmentation in comparison with semi-automated segmentation
timeFrame: Month 6
measure: Average time for segmentation in comparison with semi-automated segmentation
timeFrame: Month 12
measure: Total Volume measurement of AAA
timeFrame: 6 months before intervention
measure: Total Volume measurement of AAA
timeFrame: Month 1
measure: Total Volume measurement of AAA
timeFrame: Month 3
measure: Total Volume measurement of AAA
timeFrame: Month 6
measure: Total Volume measurement of AAA
timeFrame: Month 12
Other outcomes:
Locations:
city: Bordeaux cedex
country: France
facility: Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Eric Ducasse, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: