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RecruitingNCT06884397AORTAPREDICTUpdated Jun 18, 2025

Use of Artificial Intelligence to Predict Complications Following Abdominal Aortic Surgery

An observational study in Abdominal Aortic Aneurysms (AAA), sponsored by Groupe Hospitalier de la Rochelle Ré Aunis. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by Groupe Hospitalier de la Rochelle Ré Aunis · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Apr 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Abdominal Aortic Aneurysms (AAA)

Keywords

  • Aortic Aneurysm, Abdominal
  • Prostheses and Implants
  • Endoleak
  • Angiography, Computed Tomography
  • machine learning algorithm
03

In context

Aortic Aneurysm, Abdominal

467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.

This study's planned enrollment of 300 is above the median of 165 across 217 observational studies indexed under Aortic Aneurysm, Abdominal.

Browse Aortic Aneurysm, Abdominal studies →

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis is the lead sponsor of 22 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient treated at La Rochelle Hospital Centre for an abdominal aortic aneurysm through endovascular prosthesis implantation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Treated for an abdominal aortic aneurysm through endovascular prosthesis implantation

Exclusion criteria

Exclusion Criteria:

  • Underwent intraoperative embolization of the inferior mesenteric artery or aneurysmal sac
  • Refuse the use of their data
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Procedure: Abdominal aortic endoprosthesis

Interventions

  • ProcedureAbdominal aortic endoprosthesis

    An endoprosthesis consisting of a metal spring covered with an impermeable fabric is inserted through an artery and deployed inside the aorta.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From AAE placement to the end of the two-year follow-up

Secondary outcomes

  1. Number of embolizations

    Minimally invasive treatment that blocks one or more blood vessels or abnormal vascular channels

    Time frame: From AAE placement to the end of the two-year follow-up

  2. 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.

    Time frame: Two-year follow-up

  3. Number of serious adverse events

    deaths, ruptures, endoleaks, limb occlusions, and reinterventions

    Time frame: From AAE placement to the end of the two-year follow-up

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 30946077 ↗
  • Gentsu 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 38503637 ↗
  • Tinelli 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 ↗

Individual participant data

Plan to share: 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

Supporting information: Study protocol

Time frame: Data will be available immediately following publication.

Access criteria: Researchers who provide a methodologically sound proposal will have access to the data.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06884397
Lead sponsor
Groupe Hospitalier de la Rochelle Ré Aunis
Collaborators
La Rochelle University
Responsible party
Sponsor
First posted
Mar 19, 2025
Start date
Apr 14, 2025
Primary completion
Aug 31, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Jun 18, 2025

Study contacts

Caroline Allix-Béguec, Ph.D.
Contact
caroline.allix-beguec@ght-atlantique17.fr
+33516494246
Sébastien Franco, MD
study director · Groupe Hospitalier de la Rochelle Ré Aunis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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