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Status unknownNCT06250998ARTinEVARUpdated Apr 11, 2024

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

An observational study in AAA - Abdominal Aortic Aneurysm, sponsored by Rijnstate Hospital. Status unknown at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by Rijnstate Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • AAA - Abdominal Aortic Aneurysm

Keywords

  • AAA
  • aneurysm shrinkage
  • EVAR
  • aneurysm remodeling
  • artificial intelligence
  • AI
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In context

Aortic Aneurysm, Abdominal

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

This study's planned enrollment of 1,000 is above the median of 167 across 225 observational studies indexed under Aortic Aneurysm, Abdominal.

Browse Aortic Aneurysm, Abdominal studies →

Lead sponsor

Rijnstate Hospital is the lead sponsor of 130 studies on the registry; 14 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No
06

What researchers measure

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.

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

07

Study locations

4 of 5 sites recruiting
  • 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
08

References and documents

Publications

  • 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. PubMed 39882767 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06250998
Lead sponsor
Rijnstate Hospital
Collaborators
University Medical Center Groningen, Amsterdam UMC, location VUmc, Medisch Spectrum Twente, Karolinska Institutet
Responsible party
Sponsor
First posted
Feb 9, 2024
Start date
Apr 3, 2024
Primary completion
May 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Apr 11, 2024

Study contacts

Rianne E van Rijswijk, MSc
Contact
contact@radarconsortium.com
0031880057282

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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