Prediction of Abdominal Aortic Aneurysm Shrinkage After Stent-placement With Artificial Intelligence

NCT06250998 | Recruiting

• 1 other identifier: 2021-1986
• Study Type: observational
• Target: 1,000
• Locations: 2 countries
• Sites: 5

Brief Summary

The goal of this observational study is to find out what factors contribute to a good treatment outcome in patients who have received a stent for their dilation of the main abdominal artery (abdominal aortic aneurysm or AAA). The primary goal of this study is to build a prediction model for abdominal aortic aneurysm shrinkage one year after the treatment.

Conditions

AAA - Abdominal Aortic Aneurysm

Keywords

AAA; aneurysm shrinkage; EVAR; aneurysm remodeling; artificial intelligence; AI

Outcome Measures

Primary Outcomes (1)

• Prediction model for AAA shrinkage

  A prediction model to predict AAA shrinkage one-year after EVAR, it can consist of multiple CTA-scans and/or clinical data.

  Preoperative, peroperative and postoperative (until 1-year visit) data

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

Patients, electively treated with EVAR for an infrarenal AAA, will be included from the hospital records of 5 experienced vascular centers, 4 sites in the Netherlands and 1 site in Sweden.

You may qualify if:

• Age ≥ 18 years;
• Elective, initially technically successful (as described by the ESVS guidelines11), infrarenal EVAR for unruptured infrarenal AAA;
• Implanted endograft is a Gore Excluder, Medtronic Endurant, Cook Zenith, Cordis Incraft, Endologix AFX, Jotec E-Tegra, or Vascutek Anaconda endograft;
• Follow-up of the AAA of at least one year with imaging of the same modality as the preoperative imaging;
• Axial reconstructions of preoperative CT angiography available, preferably in the arterial phase and with 3 mm or smaller slice thickness.

You may not qualify if:

• Patients with ruptured or symptomatic AAA;
• Patients that were treated with fenestrated or branched endografts, iliac branched devices, non-CE marked devices within trial setting, other endografts (EVAS cases) or chimney procedures;
• Acute procedures;
• Reintervention before one year follow-up;
• Revision cases after previous open or endovascular aneurysm repair of an AAA;

Sponsors & Collaborators

• Rijnstate Hospital: lead
• University Medical Center Groningen: collaborator
• Amsterdam UMC, location VUmc: collaborator
• Medisch Spectrum Twente: collaborator
• Karolinska Institutet: collaborator

Study Sites (5)

Rijnstate Hospital

Arnhem, Non US/Canada, 6800 TA, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Medisch Spectrum Twente

Enschede, Netherlands

RECRUITING

Universitair Medisch Centrum Groningen

Groningen, Netherlands

RECRUITING

Karolinksa Institutet

Stockholm, Sweden

NOT YET RECRUITING

Related Publications (1)

• van Rijswijk RE, Bogdanovic M, Roy J, Yeung KK, Zeebregts CJ, Geelkerken RH, Groot Jebbink E, Wolterink JM, Reijnen MMPJ. Multimodal Artificial Intelligence Model for Prediction of Abdominal Aortic Aneurysm Shrinkage After Endovascular Repair ( the ART in EVAR study). J Endovasc Ther. 2025 Jan 30:15266028251314359. doi: 10.1177/15266028251314359. Online ahead of print.

  PMID: 39882767 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Rianne E van Rijswijk, MSc

CONTACT

0031880057282; contact@radarconsortium.com

Study Design

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

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: April 3, 2024
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

NL (4); SE (1)