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

NCT ID: NCT06250998

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-03

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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AAA - Abdominal Aortic Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

Medisch Spectrum Twente

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rijnstate Hospital

Arnhem, Non US/Canada, Netherlands

Site Status RECRUITING

Amsterdam UMC

Amsterdam, , Netherlands

Site Status RECRUITING

Medisch Spectrum Twente

Enschede, , Netherlands

Site Status RECRUITING

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Site Status RECRUITING

Karolinksa Institutet

Stockholm, , Sweden

Site Status NOT_YET_RECRUITING

Countries

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Netherlands Sweden

Central Contacts

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Rianne E van Rijswijk, MSc

Role: CONTACT

0031880057282

Facility Contacts

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Rianne E van Rijswijk, MSc

Role: primary

0031880057282

Kak Khee Yeung, MD PhD

Role: primary

0031880057282

Bob Geelkerken, MD PhD

Role: primary

0031880057282

Clark Zeebregts

Role: primary

0031880057282

Marko Bogdanovic, MD

Role: primary

0031880057282

References

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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.

Reference Type DERIVED
PMID: 39882767 (View on PubMed)

Other Identifiers

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2021-1986

Identifier Type: -

Identifier Source: org_study_id

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