Clinical Trials Directory

Trials / Completed

CompletedNCT05976711

New MRI Techniques for Diagnosis and Treatment of Patients With Abdominal Aortic Aneurysms

Gamechanger: Development of MRI Based Endovascular Procedures for Vascular Surgery

Status
Completed
Phase
Study type
Observational
Enrollment
66 (actual)
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

An abdominal aortic aneurysm (AAA) is a pathological dilatation of the aorta in the belly which can rupture leading to bleeding within the belly. To prevent rupture elective surgery can be performed. Endovascular repair (EVAR) is a surgical intervention whereby a stent is inserted into the AAA to prevent it from further growth and rupture. Standard AAA management has several drawbacks. To start: maximum AAA diameter is used to determine upon timing of elective repair but is imprecise in predicting the risk of rupture resulting in an unmet clinical need. Secondly, EVAR outcome and complication occurrence remain unpredictable due to poor prediction ability of computed tomography (CT) and ultrasound (US) utilised in the follow-up protocol. Lastly, patients and physicians are being repeatedly exposed to cumulative radiation toxicity. All these drawbacks could be solved by trading the standard imaging modalities by magnetic resonance imaging (MRI). Within the MARVY, advanced MRI techniques are used to find out if standard imaging techniques could be replaced by MRI in three phases of the AAA management (surveillance, surgery planning and post-operative follow-up). The two most important MRI techniques that will be used are 4D flow MRI and dynamic contrast enhanced (DCE) MRI which give respectively information about the blood flow within the AAA and perfusion of the aortic wall.

Conditions

Interventions

TypeNameDescription
DEVICEMagnetic resonance imaging (with PROUD software)Philips Ingenia 3.0T MR system with in-house developed PROUD software

Timeline

Start date
2023-05-04
Primary completion
2025-03-13
Completion
2025-06-12
First posted
2023-08-04
Last updated
2025-07-15

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT05976711. Inclusion in this directory is not an endorsement.