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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05964348
Acronym
AI-EVAR-FOLLOW
Enrollment
0
Registered
2023-07-27
Start date
2023-04-05
Completion date
2024-01-31
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm Aortic

Keywords

Abdominal Aortic Aneurysm, CT scan, Semi-automated analyses, Software

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.

Interventions

PROCEDURECT-Scan

semi-automated analyse by anatomical landmarks with a dedicated fully automated software

Sponsors

Nurea
CollaboratorINDUSTRY
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of length between anatomical points evolution6 months before interventionMeasurement 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 EVARMonth 1Collection 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 evolutionMonth 1Measurement of the aneurysm sac volume in cc on the CT scans available
Measurement of morphological neck characteristicsMonth 6 before interventionMeasurement of the morphological neck characteristics in mm on the CT scans available
Measurement of graft migration6 months before interventionMeasurement of the graft migration if existing on the CT scans available

Secondary

MeasureTime frameDescription
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentationMonthDescriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis
Repeatability between measures (intra observer variability)6 months before interventionDescriptive analysis of the different measurements by overlaps metric analysis
Average time for segmentation (sec)6 months before interventionThe time for segmentation by junior/senior surgeon and software is recorded
Average time for segmentation in comparison with semi-automated segmentation6 months before interventionDescription of the average time between the different techniques.
Total Volume measurement of AAA6 months before interventionDescription of the volume measurement of the AAA with the following items: * Volume circulating * Intraluminal thrombus volume * Calcification volume

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026