Use of Artificial Intelligence to Predict Complications Following Abdominal Aortic Surgery

NCT06884397 | Recruiting

• 1 other identifier: P01045
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominal Aortic Aneurysms (AAA)

Keywords

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

Outcome Measures

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.

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

Secondary Outcomes (3)

• Number of embolizations

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

• Sac size

  Two-year follow-up

• Number of serious adverse events

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

Study Arms (1)

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

Abdominal aortic endoprosthesis PROCEDURE

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

Patient treated for an abdominal aortic aneurysm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Treated for an abdominal aortic aneurysm through endovascular prosthesis implantation

You may not qualify if:

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

Sponsors & Collaborators

• Groupe Hospitalier de la Rochelle Ré Aunis: lead
• La Rochelle University: collaborator

Study Sites (1)

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

RECRUITING

Related Publications (3)

• 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.

  PMID: 30946077 BACKGROUND

• 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.

  PMID: 38503637 BACKGROUND

• 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.

  PMID: 38462062 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Endoleak

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Postoperative Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Sébastien Franco, MD

  Groupe Hospitalier de la Rochelle Ré Aunis

  STUDY DIRECTOR

Central Study Contacts

Caroline Allix-Béguec, Ph.D.

CONTACT

+33516494246; caroline.allix-beguec@ght-atlantique17.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: April 14, 2025
• Primary Completion: August 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

FR (1)