Aneurysm AorticAI-EVAR-FOLLOWNCT05964348
REGISTRY for the Use of a Software for Automatic Detection of the Evolution of Aneurysmal Volume and Graft Migration After EVAR (EndoVascular Aneurysm Repair)
An observational study of Aneurysm Aortic, run by University Hospital, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm Aortic
- What is being tested?
- CT-Scan
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2023to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux
Bordeaux, 33076
About this study
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.
- Conditions
- Aneurysm Aortic
- Being tested
- CT-Scan
- Keywords
- Abdominal Aortic Aneurysm, CT scan, Semi-automated analyses, Software
- Medical subject headings
- Aortic Aneurysm, Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-ScanProcedure or surgery
semi-automated analyse by anatomical landmarks with a dedicated fully automated software
| Study group | Role | What they receive |
|---|---|---|
| Patient with infrarenal abdominal aortic aneurysms | Patient with infrarenal abdominal aortic aneurysms treated with EVAR Receives: Procedure: CT-Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Month 12
Measurement of aneurysm sac volume evolution
Measurement of the aneurysm sac volume in cc on the CT scans available
Measured: Month 1
Measurement of aneurysm sac volume evolution
Measurement of the aneurysm sac volume in cc on the CT scans available
Measured: Month 3
Measurement of aneurysm sac volume evolution
Measurement of the aneurysm sac volume in cc on the CT scans available
Measured: Month 6
Measurement of aneurysm sac volume evolution
Measurement of the aneurysm sac volume in cc on the CT scans available
Measured: Month 12
Measurement of morphological neck characteristics
Measurement of the morphological neck characteristics in mm on the CT scans available
Measured: Month 6 before intervention
Measurement of morphological neck characteristics
Measurement of the morphological neck characteristics in mm on the CT scans available
Measured: Month 1
Measurement of morphological neck characteristics
Measurement of the morphological neck characteristics in mm on the CT scans available
Measured: Month 3
Measurement of morphological neck characteristics
Measurement of the morphological neck characteristics in mm on the CT scans available
Measured: Month 6
Measurement of morphological neck characteristics
Measurement of the morphological neck characteristics in mm on the CT scans available
Measured: Month 12
Measurement of graft migration
Measurement of the graft migration if existing on the CT scans available
Measured: 6 months before intervention
Measurement of graft migration
Measurement of the graft migration if existing on the CT scans available
Measured: Month 1
Measurement of graft migration
Measurement of the graft migration if existing on the CT scans available
Measured: Month 3
Measurement of graft migration
Measurement of the graft migration if existing on the CT scans available
Measured: Month 6
Measurement of graft migration
Measurement of the graft migration if existing on the CT scans available
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 12
Secondary outcomes (26)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Month 12
Repeatability between measures (intra observer variability)
Descriptive analysis of the different measurements by overlaps metric analysis
Measured: 6 months before intervention
Repeatability between measures (intra observer variability)
Descriptive analysis of the different measurements by overlaps metric analysis
Measured: Month 1
Repeatability between measures (intra observer variability)
Descriptive analysis of the different measurements by overlaps metric analysis
Measured: Month 3
Repeatability between measures (intra observer variability)
Descriptive analysis of the different measurements by overlaps metric analysis
Measured: Month 6
Repeatability between measures (intra observer variability)
Descriptive analysis of the different measurements by overlaps metric analysis
Measured: Month 12
Average time for segmentation (sec)
The time for segmentation by junior/senior surgeon and software is recorded
Measured: 6 months before intervention
Average time for segmentation (sec)
The time for segmentation by junior/senior surgeon and software is recorded
Measured: Month 1
Average time for segmentation (sec)
The time for segmentation by junior/senior surgeon and software is recorded
Measured: Month 3
Average time for segmentation (sec)
The time for segmentation by junior/senior surgeon and software is recorded
Measured: Month 6
Average time for segmentation (sec)
The time for segmentation by junior/senior surgeon and software is recorded
Measured: Month 12
Average time for segmentation in comparison with semi-automated segmentation
Description of the average time between the different techniques.
Measured: 6 months before intervention
Average time for segmentation in comparison with semi-automated segmentation
Description of the average time between the different techniques.
Measured: Month 1
Average time for segmentation in comparison with semi-automated segmentation
Description of the average time between the different techniques.
Measured: Month 3
Average time for segmentation in comparison with semi-automated segmentation
Description of the average time between the different techniques.
Measured: Month 6
Average time for segmentation in comparison with semi-automated segmentation
Description of the average time between the different techniques.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start5 Apr 2023
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Why it stopped: the study was no longer of scientific interest, and other publications rendered it obsolete
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm AorticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Nurea
- Responsible party
- Sponsor
- Investigators
- Eric Ducasse, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964348
- Sponsor's protocol ID
- CHUBX 2022/66
- Acronym
- AI-EVAR-FOLLOW
- Status last verified
- Jul 2023
- First submitted
- 11 May 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05964348
- Acronym / sponsor ID
- AI-EVAR-FOLLOW / CHUBX 2022/66
- Conditions
- Aneurysm Aortic
- Keywords
- Abdominal Aortic Aneurysm, CT scan, Semi-automated analyses, Software
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: the study was no longer of scientific interest, and other publications rendered it obsolete
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Nurea
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with infrarenal abdominal aortic aneurysms | – | Procedure: CT-ScanPatient with infrarenal abdominal aortic aneurysms treated with EVAR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-Scansemi-automated analyse by anatomical landmarks with a dedicated fully automated software | Procedure or surgery | Patient with infrarenal abdominal aortic aneurysms |
Primary outcome
Collection of the different events and complications of the aneurysm post EVAR
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 1
Measurement of the aneurysm sac volume in cc on the CT scans available
Measurement of aneurysm sac volume evolution
Time frame: Month 3
Measurement of the aneurysm sac volume in cc on the CT scans available
Measurement of aneurysm sac volume evolution
Time frame: Month 6
Measurement of the aneurysm sac volume in cc on the CT scans available
Measurement of aneurysm sac volume evolution
Time frame: Month 12
Measurement of the aneurysm sac volume in cc on the CT scans available
Measurement of morphological neck characteristics
Time frame: Month 6 before intervention
Measurement of the morphological neck characteristics in mm on the CT scans available
Measurement of morphological neck characteristics
Time frame: Month 1
Measurement of the morphological neck characteristics in mm on the CT scans available
Measurement of morphological neck characteristics
Time frame: Month 3
Measurement of the morphological neck characteristics in mm on the CT scans available
Measurement of morphological neck characteristics
Time frame: Month 6
Measurement of the morphological neck characteristics in mm on the CT scans available
Measurement of morphological neck characteristics
Time frame: Month 12
Measurement of the morphological neck characteristics in mm on the CT scans available
Measurement of graft migration
Time frame: 6 months before intervention
Measurement of the graft migration if existing on the CT scans available
Measurement of graft migration
Time frame: Month 1
Measurement of the graft migration if existing on the CT scans available
Measurement of graft migration
Time frame: Month 3
Measurement of the graft migration if existing on the CT scans available
Measurement of graft migration
Time frame: Month 6
Measurement of the graft migration if existing on the CT scans available
Measurement of graft migration
Time frame: Month 12
Measurement of the graft migration if existing on the CT scans available
Measurement of length between anatomical points evolution
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 12
Measurement of the length between anatomical points evolution of the aneurysm in mm on the CT scans available.
26 secondary outcomes
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
Time frame: Month
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
Time frame: 6 months before intervention
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
Time frame: Month 1
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
Time frame: Month 3
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
Time frame: Month 6
Repeatability between one senior and one junior surgeon (inter observer variability) for the Semi-automatic segmentation
Time frame: Month 12
Repeatability between measures (intra observer variability)
Time frame: 6 months before intervention
Repeatability between measures (intra observer variability)
Time frame: Month 1
Repeatability between measures (intra observer variability)
Time frame: Month 3
Repeatability between measures (intra observer variability)
Time frame: Month 6
Repeatability between measures (intra observer variability)
Time frame: Month 12
Average time for segmentation (sec)
Time frame: 6 months before intervention
Average time for segmentation (sec)
Time frame: Month 1
Average time for segmentation (sec)
Time frame: Month 3
Average time for segmentation (sec)
Time frame: Month 6
Average time for segmentation (sec)
Time frame: Month 12
Average time for segmentation in comparison with semi-automated segmentation
Time frame: 6 months before intervention
Average time for segmentation in comparison with semi-automated segmentation
Time frame: Month 1
Average time for segmentation in comparison with semi-automated segmentation
Time frame: Month 3
Average time for segmentation in comparison with semi-automated segmentation
Time frame: Month 6
Average time for segmentation in comparison with semi-automated segmentation
Time frame: Month 12
Total Volume measurement of AAA
Time frame: 6 months before intervention
Total Volume measurement of AAA
Time frame: Month 1
Total Volume measurement of AAA
Time frame: Month 3
Total Volume measurement of AAA
Time frame: Month 6
Total Volume measurement of AAA
Time frame: Month 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Ducasse, MD, PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm Aortic, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of the different events and complications of the aneurysm post EVAR (time frame: Month 1). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.