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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06250998
Other study ID # 2021-1986
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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;

Study Design


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
See also
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Not yet recruiting NCT05409118 - JAGUAR Trial (Outside United States; OUS): ObJective Analysis to GaUge EVAR Outcomes Through Randomization N/A
Not yet recruiting NCT03365050 - A Study of the Safety of Targeted AAA Screening