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 Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Aneurysm Aortic

Intervention / Treatment
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* Procedure: CT-Scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with infrarenal abdominal aortic aneurysms<br>Patient with infrarenal abdominal aortic aneurysms treated with EVAR | Procedure: CT-Scan<br>* semi-automated analyse by anatomical landmarks with a dedicated fully automated software<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal Aortic Aneurysm, CT scan, Semi-automated analyses, Software