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

AAA - Abdominal Aortic Aneurysm Clinical Trial

— ARTinEVAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250998
• Other study ID #: 2021-1986
• Status: Recruiting
• Start date: April 3, 2024
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Rijnstate Hospital
• Contact: Rianne E van Rijswijk, MSc
• Phone: 0031880057282
• Email: contact[@]radarconsortium.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• AAA - Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	Rijnstate Hospital	Arnhem	Non US/Canada
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Sweden	Karolinksa Institutet	Stockholm

Sponsors (5)

Lead Sponsor	Collaborator
Rijnstate Hospital	Amsterdam UMC, location VUmc, Karolinska Institutet, Medisch Spectrum Twente, University Medical Center Groningen

Countries where clinical trial is conducted

Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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