Abdominal Aortic Aneurysms (AAA)AORTAPREDICTNCT06884397
Use of Artificial Intelligence to Predict Complications Following Abdominal Aortic Surgery
An observational study of Abdominal Aortic Aneurysms (AAA), run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
Trial summary
Abdominal aortic aneurysm, a condition characterised by an increase in the diameter of the aorta, can be treated either surgically or endovascularly. In the latter, an endoprosthesis consisting of a metal spring covered with an impermeable fabric is inserted through an artery and deployed inside the aorta. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms (AAA)
- What is being tested?
- Abdominal aortic endoprosthesis
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patient treated at La Rochelle Hospital Centre for an abdominal aortic aneurysm through endovascular prosthesis implantation
Who may be able to join
- Treated for an abdominal aortic aneurysm through endovascular prosthesis implantation
Who cannot join
- Underwent intraoperative embolization of the inferior mesenteric artery or aneurysmal sac
- Refuse the use of their data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle
About this study
Official title: Implantation of an Endovascular Prosthesis for the Treatment of Abdominal Aortic Aneurysms: Use of a Machine Learning Model From CT Images to Predict Complications
Abdominal aortic aneurysm, a condition characterised by an increase in the diameter of the aorta, can be treated either surgically or endovascularly. In the latter, an endoprosthesis consisting of a metal spring covered with an impermeable fabric is inserted through an artery and deployed inside the aorta. This new method appears to be less invasive than surgery, but its long-term results are not yet fully understood. As a result, patients who have undergone this treatment are monitored by their surgeon to ensure that there is no endoleak. Several research teams have proposed analysing medical images to predict this risk of endoleak. Doctors are now trying to use artificial intelligence to automate the analysis of these images.
Read the detailed description
The use of endoprostheses has revolutionized the therapeutic management of patients with thoracic and/or abdominal aortic aneurysms.
In France, the placement of abdominal aortic endoprosthesis (AAE) for treating infrarenal abdominal aortic aneurysm (AAA) follows the recommendations of the French National Authority for Health (HAS) from 2001, updated in 2009 in light of medical device developments and subsequent literature data (2000-2006). It specifically states that: "endovascular treatment is less invasive than surgical treatment, allowing for reduced 30-day morbidity rates for patients eligible for both surgery and endovascular treatment." Endovascular treatment can thus be offered to patients with normal surgical risk and favorable anatomical criteria, alongside surgical treatment, after informing the patient about the benefits and risks of both methods. The vast majority of patients with AAE require regular long-term follow-up, focusing on sac dimension and volume analysis and complication management. All patients must simultaneously receive optimal treatment for their vascular risk factors and comorbidities.
The updated recommendations can be summarized as follows:
- Indications for treating asymptomatic infrarenal AAAs: AAAs with greatest diameter > 50 mm or diameter increase of more than 5 mm in six months and 10 mm in 1 year.
- A symptomatic or complicated AAA is treated regardless of size.
- Despite the absence of conclusive data, a saccular AAA is considered high-risk due to its particular morphology and is proposed for treatment even if its greatest diameter is < 50 mm.
Since 2009, the number of endoprosthetic treatments has steadily increased at the expense of open procedures, although a medical-economic evaluation has questioned the efficiency of endovascular technique in patients eligible for both techniques. The long-term benefit in preventing mortality from AAA rupture remains unestablished (the mortality benefit difference is not maintained at 4 years), and even though most patients die from their comorbidities rather than their aneurysm, the first deaths from late rupture (beyond the fifth year of implantation) have appeared in long-term follow-up studies.
Concurrently, these studies have shown that nearly half of treated patients will require one or more additional procedures in subsequent years, and among treated patients:
- Only those showing aneurysmal sac shrinkage are considered cured.
- An average volume reduction of 3.2% would be sufficient to prevent endoleak occurrence.
- Conversely, a volume increase of more than 2% would be significantly associated with endoleak existence.
Endoleak is the most common complication after AAE placement, with incidence varying greatly depending on type and time elapsed since endoprosthesis placement. It is defined by blood circulation between the AAE and the arterial wall of the AAA. Five types of endoleak have been described according to anatomical, chronological, or physiological characteristics:
- Type I Endoleak: Ia) proximal anterograde peri-prosthetic flow due to endoprosthesis fixation failure, Ib) distal retrograde peri-prosthetic flow due to endoprosthesis fixation failure, Ic) iliac occluder seal failure,
- Type II Endoleak: retrograde flow from lumbar artery(ies) or inferior mesenteric artery feeding the aneurysmal sac: IIa) reperfusion through inferior mesenteric artery, IIb) reperfusion through lumbar artery(ies)
- Type III Endoleaks: IIIa) separation of modular endoprosthesis components, IIIb) fabric degradation. Endoleaks indicating early mechanical failure or premature fatigue of the endoprosthesis, potentially facilitated by AAA morphological changes, particularly its retraction
- Type IV Endoleaks: excessive endoprosthesis porosity. Generally early (<30 days post-implantation), initially described but now almost non-existent due to fabric improvements
- Type V Endoleak: residual hyperpressure in the aneurysmal sac without obvious cause (no individualized leak) associated with AAA size increase. It warrants thorough investigation for endoleak and may lead to explantation.
Several teams have proposed preoperative criteria to predict endoleak risk (preoperative inferior mesenteric artery patency, sac size), but without real evidence. Some teams propose preventive embolizations based on these criteria (pre- or during procedure).
The investigators propose to evaluate whether a machine learning algorithm can predict endoleak risk from initial CT scan images.
- Conditions
- Abdominal Aortic Aneurysms (AAA)
- Being tested
- Abdominal aortic endoprosthesis
- Keywords
- Aortic Aneurysm, Abdominal, Prostheses and Implants, Endoleak, Angiography, Computed Tomography, machine learning algorithm
- Medical subject headings
- Aortic Aneurysm, Abdominal, Endoleak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal aortic endoprosthesisProcedure or surgery
An endoprosthesis consisting of a metal spring covered with an impermeable fabric is inserted through an artery and deployed inside the aorta.
| Study group | Role | What they receive |
|---|---|---|
| Patient treated for an abdominal aortic aneurysm | Indications for infrarenal abdominal aortic aneurysm (AAA) treatment with abdominal aortic endoprosthesis (AAE) were :
* AAAs with greatest diameter > 50 mm for women and > 55 mm for men, or diameter increase of more than 5 mm in six months and 10 mm in 1 year.
* A symptomatic or complicated AAA is treated regardless of size.
* Despite the absence of conclusive data, a saccular AAA is considered high-risk due to its particular morphology and is proposed for treatment even if its greatest diameter is < 50 mm. Receives: Procedure: Abdominal aortic endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of endoleaks following endograft implantation
Endoleak is the most common complication after AAE placement, with incidence varying greatly depending on type and time elapsed since endoprosthesis placement. It is defined by blood circulation between the AAE and the arterial wall of the AAA. Five types of endoleak have been described according to anatomical, chronological, or physiological characteristics.
Measured: From AAE placement to the end of the two-year follow-up
Secondary outcomes (3)
Number of embolizations
Minimally invasive treatment that blocks one or more blood vessels or abnormal vascular channels
Measured: From AAE placement to the end of the two-year follow-up
Sac size
Normal aortic diameter varies with age, sex, and body habitus, but the average diameter of the adult human infrarenal aorta is approximately 2.0 cm. In most adults, an aortic diameter >3.0 cm is generally considered aneurysmal.
Measured: Two-year follow-up
Number of serious adverse events
deaths, ruptures, endoleaks, limb occlusions, and reinterventions
Measured: From AAE placement to the end of the two-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start14 Apr 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic Aneurysms (AAA)Studies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Collaborators
- La Rochelle University
- Responsible party
- Sponsor
- Investigators
- Sébastien Franco, MD, Study director, Groupe Hospitalier de la Rochelle Ré Aunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884397
- Sponsor's protocol ID
- P01045
- Acronym
- AORTAPREDICT
- Status last verified
- Jun 2025
- First submitted
- 13 Mar 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available with publication. A Digital Object Identifier will be used and Data will be available at www.recherche.data.gouv.fr
Publications
Samura M, Morikage N, Otsuka R, Mizoguchi T, Takeuchi Y, Nagase T, Harada T, Yamashita O, Suehiro K, Hamano K. Endovascular Aneurysm Repair With Inferior Mesenteric Artery Embolization for Preventing Type II Endoleak: A Prospective Randomized Controlled Trial. Ann Surg. 2020 Feb;271(2):238-244. doi: 10.1097/SLA.0000000000003299.
PubMed 30946077Gentsu T, Yamaguchi M, Sasaki K, Kawasaki R, Horinouchi H, Fukuda T, Miyamoto N, Mori T, Sakamoto N, Uotani K, Taniguchi T, Koda Y, Yamanaka K, Takahashi H, Okada K, Hayashi T, Watanabe T, Nomura Y, Matsushiro K, Ueshima E, Okada T, Sugimoto K, Murakami T. Side branch embolization before endovascular abdominal aortic aneurysm repair to prevent type II endoleak: A prospective multicenter study. Diagn Interv Imaging. 2024 Sep;105(9):326-335. doi: 10.1016/j.diii.2024.03.003. Epub 2024 Mar 19.
PubMed 38503637Tinelli G, D'Oria M, Sica S, Mani K, Rancic Z, Resch TA, Beccia F, Azizzadeh A, Da Volta Ferreira MM, Gargiulo M, Lepidi S, Tshomba Y, Oderich GS, Haulon S; SLIM F-U EVAR, Collaborative Study Group. The sac evolution imaging follow-up after endovascular aortic repair: An international expert opinion-based Delphi consensus study. J Vasc Surg. 2024 Sep;80(3):937-945. doi: 10.1016/j.jvs.2024.03.007. Epub 2024 Mar 8.
PubMed 38462062
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of an Endovascular Prosthesis for the Treatment of Abdominal Aortic Aneurysms: Use of a Machine Learning Model From CT Images to Predict Complications
- ClinicalTrials.gov ID
- NCT06884397
- Acronym / sponsor ID
- AORTAPREDICT / P01045
- Conditions
- Abdominal Aortic Aneurysms (AAA)
- Keywords
- Aortic Aneurysm, Abdominal, Prostheses and Implants, Endoleak, Angiography, Computed Tomography, machine learning algorithm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Collaborators
- La Rochelle University
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Mar 2025 (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.
Abdominal aortic aneurysm, a condition characterised by an increase in the diameter of the aorta, can be treated either surgically or endovascularly. In the latter, an endoprosthesis consisting of a metal spring covered with an impermeable fabric is inserted through an artery and deployed inside the aorta. This new method appears to be less invasive than surgery, but its long-term results are not yet fully understood. As a result, patients who have undergone this treatment are monitored by their surgeon to ensure that there is no endoleak. Several research teams have proposed analysing medical images to predict this risk of endoleak. Doctors are now trying to use artificial intelligence to automate the analysis of these images.
Detailed description
The use of endoprostheses has revolutionized the therapeutic management of patients with thoracic and/or abdominal aortic aneurysms.
In France, the placement of abdominal aortic endoprosthesis (AAE) for treating infrarenal abdominal aortic aneurysm (AAA) follows the recommendations of the French National Authority for Health (HAS) from 2001, updated in 2009 in light of medical device developments and subsequent literature data (2000-2006). It specifically states that: "endovascular treatment is less invasive than surgical treatment, allowing for reduced 30-day morbidity rates for patients eligible for both surgery and endovascular treatment." Endovascular treatment can thus be offered to patients with normal surgical risk and favorable anatomical criteria, alongside surgical treatment, after informing the patient about the benefits and risks of both methods. The vast majority of patients with AAE require regular long-term follow-up, focusing on sac dimension and volume analysis and complication management. All patients must simultaneously receive optimal treatment for their vascular risk factors and comorbidities.
The updated recommendations can be summarized as follows:
- Indications for treating asymptomatic infrarenal AAAs: AAAs with greatest diameter > 50 mm or diameter increase of more than 5 mm in six months and 10 mm in 1 year.
- A symptomatic or complicated AAA is treated regardless of size.
- Despite the absence of conclusive data, a saccular AAA is considered high-risk due to its particular morphology and is proposed for treatment even if its greatest diameter is < 50 mm.
Since 2009, the number of endoprosthetic treatments has steadily increased at the expense of open procedures, although a medical-economic evaluation has questioned the efficiency of endovascular technique in patients eligible for both techniques. The long-term benefit in preventing mortality from AAA rupture remains unestablished (the mortality benefit difference is not maintained at 4 years), and even though most patients die from their comorbidities rather than their aneurysm, the first deaths from late rupture (beyond the fifth year of implantation) have appeared in long-term follow-up studies.
Concurrently, these studies have shown that nearly half of treated patients will require one or more additional procedures in subsequent years, and among treated patients:
- Only those showing aneurysmal sac shrinkage are considered cured.
- An average volume reduction of 3.2% would be sufficient to prevent endoleak occurrence.
- Conversely, a volume increase of more than 2% would be significantly associated with endoleak existence.
Endoleak is the most common complication after AAE placement, with incidence varying greatly depending on type and time elapsed since endoprosthesis placement. It is defined by blood circulation between the AAE and the arterial wall of the AAA. Five types of endoleak have been described according to anatomical, chronological, or physiological characteristics:
- Type I Endoleak: Ia) proximal anterograde peri-prosthetic flow due to endoprosthesis fixation failure, Ib) distal retrograde peri-prosthetic flow due to endoprosthesis fixation failure, Ic) iliac occluder seal failure,
- Type II Endoleak: retrograde flow from lumbar artery(ies) or inferior mesenteric artery feeding the aneurysmal sac: IIa) reperfusion through inferior mesenteric artery, IIb) reperfusion through lumbar artery(ies)
- Type III Endoleaks: IIIa) separation of modular endoprosthesis components, IIIb) fabric degradation. Endoleaks indicating early mechanical failure or premature fatigue of the endoprosthesis, potentially facilitated by AAA morphological changes, particularly its retraction
- Type IV Endoleaks: excessive endoprosthesis porosity. Generally early (<30 days post-implantation), initially described but now almost non-existent due to fabric improvements
- Type V Endoleak: residual hyperpressure in the aneurysmal sac without obvious cause (no individualized leak) associated with AAA size increase. It warrants thorough investigation for endoleak and may lead to explantation.
Several teams have proposed preoperative criteria to predict endoleak risk (preoperative inferior mesenteric artery patency, sac size), but without real evidence. Some teams propose preventive embolizations based on these criteria (pre- or during procedure).
The investigators propose to evaluate whether a machine learning algorithm can predict endoleak risk from initial CT scan images.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient treated for an abdominal aortic aneurysm | – | Procedure: Abdominal aortic endoprosthesisIndications for infrarenal abdominal aortic aneurysm (AAA) treatment with abdominal aortic endoprosthesis (AAE) were : * AAAs with greatest diameter > 50 mm for women and > 55 mm for men, or diameter increase of more than 5 mm in six months and 10 mm in 1 year. * A symptomatic or complicated AAA is treated regardless of size. * Despite the absence of conclusive data, a saccular AAA is considered high-risk due to its particular morphology and is proposed for treatment even if its greatest diameter is < 50 mm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient treated at La Rochelle Hospital Centre for an abdominal aortic aneurysm through endovascular prosthesis implantation
Key inclusion criteria (1 listed)
- Treated for an abdominal aortic aneurysm through endovascular prosthesis implantation
Key exclusion criteria (2 listed)
- Underwent intraoperative embolization of the inferior mesenteric artery or aneurysmal sac
- Refuse the use of their data
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 |
|---|---|---|
| Abdominal aortic endoprosthesisAn endoprosthesis consisting of a metal spring covered with an impermeable fabric is inserted through an artery and deployed inside the aorta. | Procedure or surgery | Patient treated for an abdominal aortic aneurysm |
Primary outcome
Number of endoleaks following endograft implantation
Time frame: From AAE placement to the end of the two-year follow-up
Endoleak is the most common complication after AAE placement, with incidence varying greatly depending on type and time elapsed since endoprosthesis placement. It is defined by blood circulation between the AAE and the arterial wall of the AAA. Five types of endoleak have been described according to anatomical, chronological, or physiological characteristics.
3 secondary outcomes
Number of embolizations
Time frame: From AAE placement to the end of the two-year follow-up
Sac size
Time frame: Two-year follow-up
Number of serious adverse events
Time frame: From AAE placement to the end of the two-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Background: PubMed 30946077Samura M, Morikage N, Otsuka R, Mizoguchi T, Takeuchi Y, Nagase T, Harada T, Yamashita O, Suehiro K, Hamano K. Endovascular Aneurysm Repair With Inferior Mesenteric Artery Embolization for Preventing Type II Endoleak: A Prospective Randomized Controlled Trial. Ann Surg. 2020 Feb;271(2):238-244. doi: 10.1097/SLA.0000000000003299.
- Background: PubMed 38503637Gentsu T, Yamaguchi M, Sasaki K, Kawasaki R, Horinouchi H, Fukuda T, Miyamoto N, Mori T, Sakamoto N, Uotani K, Taniguchi T, Koda Y, Yamanaka K, Takahashi H, Okada K, Hayashi T, Watanabe T, Nomura Y, Matsushiro K, Ueshima E, Okada T, Sugimoto K, Murakami T. Side branch embolization before endovascular abdominal aortic aneurysm repair to prevent type II endoleak: A prospective multicenter study. Diagn Interv Imaging. 2024 Sep;105(9):326-335. doi: 10.1016/j.diii.2024.03.003. Epub 2024 Mar 19.
- Background: PubMed 38462062Tinelli G, D'Oria M, Sica S, Mani K, Rancic Z, Resch TA, Beccia F, Azizzadeh A, Da Volta Ferreira MM, Gargiulo M, Lepidi S, Tshomba Y, Oderich GS, Haulon S; SLIM F-U EVAR, Collaborative Study Group. The sac evolution imaging follow-up after endovascular aortic repair: An international expert opinion-based Delphi consensus study. J Vasc Surg. 2024 Sep;80(3):937-945. doi: 10.1016/j.jvs.2024.03.007. Epub 2024 Mar 8.
- Individual participant dataSharing planned: Yes. Data will be made available with publication. A Digital Object Identifier will be used and Data will be available at www.recherche.data.gouv.fr
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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.
Sébastien Franco, MD study director
Groupe Hospitalier de la Rochelle Ré Aunis
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 Aneurysms (AAA), run by Groupe Hospitalier de la Rochelle Ré Aunis 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 18 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Allix-Béguec, Ph.D. (+33516494246, caroline.allix-beguec@ght-atlantique17.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of endoleaks following endograft implantation (time frame: From AAE placement to the end of the two-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06884397, which also lists 3 linked publications.
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 18 Jun 2025.