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

Recruiting

• Conditions: AAA - Abdominal Aortic Aneurysm

• Registration Number: NCT06250998
• Lead Sponsor: Rijnstate Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-09
• Status Verified: 2024-04
• Study Start: 2024-04-03
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11
• Primary Completion: 2024-05
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prediction model for AAA shrinkage	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.

Trial Locations

Locations (5)

Rijnstate Hospital; 🇳🇱 Arnhem, Non US/Canada, Netherlands

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

Karolinksa Institutet; 🇸🇪 Stockholm, Sweden