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the study was no longer of scientific interest, and other publications rendered it obsolete
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| Name | Class |
|---|---|
| Nurea | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with infrarenal abdominal aortic aneurysms | Patient with infrarenal abdominal aortic aneurysms treated with EVAR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-Scan | Procedure | semi-automated analyse by anatomical landmarks with a dedicated fully automated software |
|
| 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 |
| 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 |
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Inclusion Criteria:
Male or female ≥18 years of age
Infra-renal Abdominal Aortic Aneurysm (AAA) treated with EVAR
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:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Eric Ducasse, MD, PhD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux | Bordeaux | 33076 | France |
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| 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 |
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:
| 6 months before intervention |
| Total Volume measurement of AAA | Description of the volume measurement of the AAA with the following items:
| Month 1 |
| Total Volume measurement of AAA | Description of the volume measurement of the AAA with the following items:
| Month 3 |
| Total Volume measurement of AAA | Description of the volume measurement of the AAA with the following items:
| Month 6 |
| Total Volume measurement of AAA | Description of the volume measurement of the AAA with the following items:
| Month 12 |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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