AI-EVAR-FOLLOW: 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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Collection of the different events and complications of the aneurysm post EVAR [Month 1]
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
- Collection of the different events and complications of the aneurysm post EVAR [Month 3]
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
- Collection of the different events and complications of the aneurysm post EVAR [Month 6]
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
- 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 1]
Measurement of the aneurysm sac volume in cc on the CT scans available
- Measurement of aneurysm sac volume evolution [Month 3]
Measurement of the aneurysm sac volume in cc on the CT scans available
- Measurement of aneurysm sac volume evolution [Month 6]
Measurement of the aneurysm sac volume in cc on the CT scans available
- Measurement of aneurysm sac volume evolution [Month 12]
Measurement of the aneurysm sac volume in cc on the CT scans available
- Measurement of morphological neck characteristics [Month 6 before intervention]
Measurement of the morphological neck characteristics in mm on the CT scans available
- Measurement of morphological neck characteristics [Month 1]
Measurement of the morphological neck characteristics in mm on the CT scans available
- Measurement of morphological neck characteristics [Month 3]
Measurement of the morphological neck characteristics in mm on the CT scans available
- Measurement of morphological neck characteristics [Month 6]
Measurement of the morphological neck characteristics in mm 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
- Measurement of graft migration [6 months before intervention]
Measurement of the graft migration if existing on the CT scans available
- Measurement of graft migration [Month 1]
Measurement of the graft migration if existing on the CT scans available
- Measurement of graft migration [Month 3]
Measurement of the graft migration if existing on the CT scans available
- Measurement of graft migration [Month 6]
Measurement of the graft migration if existing 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 length between anatomical points evolution [6 months before intervention]
Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.
- Measurement of length between anatomical points evolution [Month 1]
Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.
- Measurement of length between anatomical points evolution [Month 3]
Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.
- Measurement of length between anatomical points evolution [Month 6]
Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.
- 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.
Secondary Outcome Measures
- Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation [Month]
Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis
- Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation [6 months before intervention]
Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis
- Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation [Month 1]
Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis
- Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation [Month 3]
Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis
- Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation [Month 6]
Descriptive analysis of the semi-automatic segmentation for the junior and senior surgeon by overlaps metric analysis
- 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
- Repeatability between measures (intra observer variability) [6 months before intervention]
Descriptive analysis of the different measurements by overlaps metric analysis
- Repeatability between measures (intra observer variability) [Month 1]
Descriptive analysis of the different measurements by overlaps metric analysis
- Repeatability between measures (intra observer variability) [Month 3]
Descriptive analysis of the different measurements by overlaps metric analysis
- Repeatability between measures (intra observer variability) [Month 6]
Descriptive analysis of the different measurements by overlaps metric analysis
- Repeatability between measures (intra observer variability) [Month 12]
Descriptive analysis of the different measurements by overlaps metric analysis
- Average time for segmentation (sec) [6 months before intervention]
The time for segmentation by junior/senior surgeon and software is recorded
- Average time for segmentation (sec) [Month 1]
The time for segmentation by junior/senior surgeon and software is recorded
- Average time for segmentation (sec) [Month 3]
The time for segmentation by junior/senior surgeon and software is recorded
- Average time for segmentation (sec) [Month 6]
The time for segmentation by junior/senior surgeon and software is recorded
- Average time for segmentation (sec) [Month 12]
The time for segmentation by junior/senior surgeon and software is recorded
- Average time for segmentation in comparison with semi-automated segmentation [6 months before intervention]
Description of the average time between the different techniques.
- Average time for segmentation in comparison with semi-automated segmentation [Month 1]
Description of the average time between the different techniques.
- Average time for segmentation in comparison with semi-automated segmentation [Month 3]
Description of the average time between the different techniques.
- Average time for segmentation in comparison with semi-automated segmentation [Month 6]
Description of the average time between the different techniques.
- 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 [6 months before intervention]
Description of the volume measurement of the AAA with the following items: Volume circulating Intraluminal thrombus volume Calcification volume
- Total Volume measurement of AAA [Month 1]
Description of the volume measurement of the AAA with the following items: Volume circulating Intraluminal thrombus volume Calcification volume
- Total Volume measurement of AAA [Month 3]
Description of the volume measurement of the AAA with the following items: Volume circulating Intraluminal thrombus volume Calcification volume
- Total Volume measurement of AAA [Month 6]
Description of the volume measurement of the AAA with the following items: Volume circulating Intraluminal thrombus volume Calcification volume
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux | Bordeaux cedex | France | 33076 |
Sponsors and Collaborators
- University Hospital, Bordeaux
- Nurea
Investigators
- Principal Investigator: Eric Ducasse, MD, PhD, University Hospital, Bordeaux
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHUBX 2022/66