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

April 10, 2024 updated by: Rijnstate Hospital

Prediction of Abdominal Aortic Aneurysm Shrinkage After Endovascular Repair With Artificial Intelligence

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
      • Enschede, Netherlands
      • Groningen, Netherlands
        • Recruiting
        • Universitair Medisch Centrum Groningen
        • Contact:
    • Non US/Canada
      • Arnhem, Non US/Canada, Netherlands, 6800 TA
        • Recruiting
        • Rijnstate Hospital
        • Contact:
        • Principal Investigator:
          • Michel MP Reijnen, MD PhD
  • Sweden
      • Stockholm, Sweden
        • Not yet recruiting
        • Karolinksa Institutet
        • Contact:
        • Principal Investigator:
          • Joy Roy, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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:

  • 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction model for AAA shrinkage
Time Frame: Preoperative, peroperative and postoperative (until 1-year visit) data
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Collaborators

Karolinska Institutet
University Medical Center Groningen
Amsterdam UMC, location VUmc
Medisch Spectrum Twente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2024

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-1986

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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