Abdominal Aortic AneurysmIAVASCNCT06451315
REGISTRY on the Implementation of Artificial Intelligence in the Automatic Analysis of Vascular Network Segmentation
An observational study of Abdominal Aortic Aneurysm, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The team hypothesizes that fully automatic analysis of AAA could provide increased performance (decreased duration of segmentation with increased reproducibility and decreased inter and intraobserver variability) to detect aortic aneurysmal sac enlargement (volumes and diameters) and predict the risk of complications… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Analyze CTscans pre-operatively by Nurea System and Analyze CTscans pre-operatively by hospital practitioner
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2024to 15 Jul 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
- No healthy volunteers
- Adult, Older adult
Study population: The patient came to the vascular surgery unit for his post-operative follow-up visit who have had surgery for Abdominal Aortic Aneurysm
Who may be able to join
- Male or female ≥18 years of age
- AAA treated with EVAR between
- ≥50mm
- or ≥5mm increase in 6 months
- The subject is legally competent, has been informed of the nature, the scope, and the relevance of the study and has not manifested an opposition to participate.
- Available for set-up and proper implementation of follow-up visits (standard of care) 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 woman
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Vasculaire, Hôpital Pellegrin-tripode, CHU de Bordeaux
Bordeaux, 33076
Eric Ducasse, MD, PhD, 33 (0) 5 56 79 55 25, eric.ducasse@chu-bordeaux.fr
Eric DUCASSE, MD, PhD
About this study
The team hypothesizes that fully automatic analysis of AAA could provide increased performance (decreased duration of segmentation with increased reproducibility and decreased inter and intraobserver variability) to detect aortic aneurysmal sac enlargement (volumes and diameters) and predict the risk of complications during the procedure and during follow-up (MAE, MACE, MALE, Stroke) compared to standard methods of measurement relying on approximate maximum sac diameter.
Read the detailed description
An abdominal aortic aneurysm (AAA) is an abnormal dilation of the abdominal aortic wall. The most catastrophic consequence of AAA increase evolution is aortic rupture, which still results in high morbidity and mortality. Accurate measurement of AAAs is necessary to predict the risk of rupture during evolution, to take adequate decisions to treat or not the patient as well as detect general and technical risk factors and to follow aneurysm sac behavior after endovascular aortic repair (EVAR).
Despite the widespread use of diameter measurements in clinical trials and its ease of ascertainment in clinical practice for monitoring of AAAs; clinical decision-making regarding the timing of aneurysm repair and even surveillance of sac expansion after EVAR, several studies have concluded that the diameter may not be reliable as a rupture risk criterion and that it should be replaced by more specifics criteria.
Volumetric assessment of the aneurysm is bound to be a better predictor of AAA expansion and risk of rupture. Recently, there has been considerable progress in segmentation software, allowing a semi-automatic calculation of accurate volumes from CTAs. However, despite ample evidence, volumetry has largely remained in the research domain and is still not carried out in most institutions. The major reason is that segmentation methods are time-consuming, they do not allow co-registration of interval studies and they require dedicated software and skilled technicians, which may be difficult to organize.
Innovative software PREAVAorta of Nurea company, using artificial intelligence with deep learning approaches, is able to reconstruct automatically the vascular structures from CT scans. As current solutions only reconstruct the lumen, Nurea's software also segments automatically aneurysms and associated thrombus. With this reconstruction, the software is able to provide diameters (and in particular maximum diameters) but also aneurysmal sac volume. It is the first solution providing automatic AAA volume and comparative evolution during follow-up. In addition, the software provides distances between anatomic points, calcification volume and measurement evolutions between different time points. The software also automatically detects and quantifies calcifications and stenosis on peripheral arteries, which is currently evaluated on the same or independent CT scans for predictive factor analysis, especially with regard to stroke risk for carotid stenosis and accesses, technical difficulties and predictors or MACE (Major Adverse Coronary Event) or MALE (Major Adverse Limb Event) for iliac and femoral arteries.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Analyze CTscans pre-operatively by Nurea System, Analyze CTscans pre-operatively by hospital practitioner
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analyze CTscans pre-operatively by Nurea SystemProcedure or surgery
CTscans will be analyzed pre-operatively (6 months before intervention) and post-operatively with an early control scan (up to one-month post-EVAR), compared to a 3, 6 and 12-month control scan by system develop by Nurea
Analyze CTscans pre-operatively by hospital practitionerProcedure or surgery
CTscans will be analyzed pre-operatively (6 months before intervention) and post-operatively with an early control scan (up to one-month post-EVAR), compared to a 3, 6 and 12-month control scan by an hospital practitioner
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Aortic Aneurysm (AAA) treated with EndoVascular Aneurysm Repair (EVAR) | Male or female ≥18 years of age with AAA treated with EVAR between ≥50mm or ≥5mm increase in 6 months. The subject is legally competent, has been informed of the nature, the scope, and the relevance of the study and has not manifested an opposition to participate. He is available for set-up and proper implementation of follow-up visits (standard of care) throughout the duration of the registry Receives: Procedure: Analyze CTscans pre-operatively by Nurea System; Procedure: Analyze CTscans pre-operatively by hospital practitioner |
What is being measured
The primary outcome is the main question the study is designed to answer.
global volume measure of the aneurysm
global volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: 6 months before surgery
global volume measure of the aneurysm
global volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: Day 3
global volume measure of the aneurysm
global volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: Month 3
global volume measure of the aneurysm
global volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: Month 6
global volume measure of the aneurysm
global volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: Month 12
Secondary outcomes (15)
lumen volume measure of the aneurysm
lumen volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: 6 months before surgery
lumen volume measure of the aneurysm
lumen volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: Day 3
lumen volume measure of the aneurysm
lumen volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: Month 3
lumen volume measure of the aneurysm
lumen volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: Month 6
lumen volume measure of the aneurysm
lumen volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: Month 12
thrombus volume measure of the aneurysm
thrombus volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: 6 months before surgery
thrombus volume measure of the aneurysm
thrombus volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: Day 3
thrombus volume measure of the aneurysm
thrombus volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: Month 3
thrombus volume measure of the aneurysm
thrombus volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: Month 6
thrombus volume measure of the aneurysm
thrombus volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: Month 12
calcification volume measure of the aneurysm
calcification volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: 6 months before surgery
calcification volume measure of the aneurysm
calcification volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: Day 3
calcification volume measure of the aneurysm
calcification volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: Month 3
calcification volume measure of the aneurysm
calcification volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
Measured: Month 6
calcification volume measure of the aneurysm
calcification volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
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 posted11 Jun 2024
- Study start30 Jan 2024
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- 250 participants (estimated)
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
- NCT06451315
- Sponsor's protocol ID
- CHUBX 2023/77
- Acronym
- IAVASC
- Status last verified
- May 2024
- First submitted
- 31 May 2024
- Last updated
- 13 Jun 2024
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REGISTRY on the Implementation of Artificial Intelligence in the Automatic Analysis of Vascular Network Segmentation
- ClinicalTrials.gov ID
- NCT06451315
- Acronym / sponsor ID
- IAVASC / CHUBX 2023/77
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Nurea
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 11 Jun 2024 (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 team hypothesizes that fully automatic analysis of AAA could provide increased performance (decreased duration of segmentation with increased reproducibility and decreased inter and intraobserver variability) to detect aortic aneurysmal sac enlargement (volumes and diameters) and predict the risk of complications during the procedure and during follow-up (MAE, MACE, MALE, Stroke) compared to standard methods of measurement relying on approximate maximum sac diameter.
Detailed description
An abdominal aortic aneurysm (AAA) is an abnormal dilation of the abdominal aortic wall. The most catastrophic consequence of AAA increase evolution is aortic rupture, which still results in high morbidity and mortality. Accurate measurement of AAAs is necessary to predict the risk of rupture during evolution, to take adequate decisions to treat or not the patient as well as detect general and technical risk factors and to follow aneurysm sac behavior after endovascular aortic repair (EVAR).
Despite the widespread use of diameter measurements in clinical trials and its ease of ascertainment in clinical practice for monitoring of AAAs; clinical decision-making regarding the timing of aneurysm repair and even surveillance of sac expansion after EVAR, several studies have concluded that the diameter may not be reliable as a rupture risk criterion and that it should be replaced by more specifics criteria.
Volumetric assessment of the aneurysm is bound to be a better predictor of AAA expansion and risk of rupture. Recently, there has been considerable progress in segmentation software, allowing a semi-automatic calculation of accurate volumes from CTAs. However, despite ample evidence, volumetry has largely remained in the research domain and is still not carried out in most institutions. The major reason is that segmentation methods are time-consuming, they do not allow co-registration of interval studies and they require dedicated software and skilled technicians, which may be difficult to organize.
Innovative software PREAVAorta of Nurea company, using artificial intelligence with deep learning approaches, is able to reconstruct automatically the vascular structures from CT scans. As current solutions only reconstruct the lumen, Nurea's software also segments automatically aneurysms and associated thrombus. With this reconstruction, the software is able to provide diameters (and in particular maximum diameters) but also aneurysmal sac volume. It is the first solution providing automatic AAA volume and comparative evolution during follow-up. In addition, the software provides distances between anatomic points, calcification volume and measurement evolutions between different time points. The software also automatically detects and quantifies calcifications and stenosis on peripheral arteries, which is currently evaluated on the same or independent CT scans for predictive factor analysis, especially with regard to stroke risk for carotid stenosis and accesses, technical difficulties and predictors or MACE (Major Adverse Coronary Event) or MALE (Major Adverse Limb Event) for iliac and femoral arteries.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal Aortic Aneurysm (AAA) treated with EndoVascular Aneurysm Repair (EVAR) | – | Procedure: Analyze CTscans pre-operatively by Nurea System, Procedure: Analyze CTscans pre-operatively by hospital practitionerMale or female ≥18 years of age with AAA treated with EVAR between ≥50mm or ≥5mm increase in 6 months. The subject is legally competent, has been informed of the nature, the scope, and the relevance of the study and has not manifested an opposition to participate. He is available for set-up and proper implementation of follow-up visits (standard of care) throughout the duration of the registry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient came to the vascular surgery unit for his post-operative follow-up visit who have had surgery for Abdominal Aortic Aneurysm
Key inclusion criteria (6 listed)
- Male or female ≥18 years of age
- AAA treated with EVAR between
- The subject is legally competent, has been informed of the nature, the scope, and the relevance of the study and has not manifested an opposition to participate.
- Available for set-up and proper implementation of follow-up visits (standard of care) throughout the duration of the registry
Key exclusion criteria (4 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 woman
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 |
|---|---|---|
| Analyze CTscans pre-operatively by Nurea SystemCTscans will be analyzed pre-operatively (6 months before intervention) and post-operatively with an early control scan (up to one-month post-EVAR), compared to a 3, 6 and 12-month control scan by system develop by Nurea | Procedure or surgery | Abdominal Aortic Aneurysm (AAA) treated with EndoVascular Aneurysm Repair (EVAR) |
| Analyze CTscans pre-operatively by hospital practitionerCTscans will be analyzed pre-operatively (6 months before intervention) and post-operatively with an early control scan (up to one-month post-EVAR), compared to a 3, 6 and 12-month control scan by an hospital practitioner | Procedure or surgery | Abdominal Aortic Aneurysm (AAA) treated with EndoVascular Aneurysm Repair (EVAR) |
Primary outcome
global volume measure of the aneurysm
Time frame: 6 months before surgery
global volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
global volume measure of the aneurysm
Time frame: Day 3
global volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
global volume measure of the aneurysm
Time frame: Month 3
global volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
global volume measure of the aneurysm
Time frame: Month 6
global volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
global volume measure of the aneurysm
Time frame: Month 12
global volume measure of the aneurysm by CT-scan. Data are retrospectively collected from the preoperative period (6 months before intervention), during hospitalisation and at systematic follow-up visits at 3, 6 and 12 months after surgery.
15 secondary outcomes
lumen volume measure of the aneurysm
Time frame: 6 months before surgery
lumen volume measure of the aneurysm
Time frame: Day 3
lumen volume measure of the aneurysm
Time frame: Month 3
lumen volume measure of the aneurysm
Time frame: Month 6
lumen volume measure of the aneurysm
Time frame: Month 12
thrombus volume measure of the aneurysm
Time frame: 6 months before surgery
thrombus volume measure of the aneurysm
Time frame: Day 3
thrombus volume measure of the aneurysm
Time frame: Month 3
thrombus volume measure of the aneurysm
Time frame: Month 6
thrombus volume measure of the aneurysm
Time frame: Month 12
calcification volume measure of the aneurysm
Time frame: 6 months before surgery
calcification volume measure of the aneurysm
Time frame: Day 3
calcification volume measure of the aneurysm
Time frame: Month 3
calcification volume measure of the aneurysm
Time frame: Month 6
calcification volume measure of the aneurysm
Time frame: Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
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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 Abdominal Aortic Aneurysm, 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 4 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric DUCASSE, MD, PhD (+33 5 56 79 55 25, eric.ducasse@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global volume measure of the aneurysm (time frame: 6 months before surgery). The study lists 5 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 13 Jun 2024.