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

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

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-04

Study Completion Date

2025-06-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Abdominal Aortic Aneurysm Without Rupture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surveillance

20 AAA patients will undergo two MRI scans with a half year interval to assess a possible correlation between MRI derived biomarkers and the clinical standard to assess aneurysm progression (maximum AAA diameter).

Magnetic resonance imaging (with PROUD software)

Intervention Type DEVICE

Philips Ingenia 3.0T MR system with in-house developed PROUD software

EVAR planning

10 patients will undergo magnetic resonance angiography next to the standard of CT angiography (CTA). It is investigated whether EVAR planning is feasible based on MRA and if or how measurements between MRA and CTA differ.

Magnetic resonance imaging (with PROUD software)

Intervention Type DEVICE

Philips Ingenia 3.0T MR system with in-house developed PROUD software

EVAR follow-up

30 AAA patients who underwent EVAR will be included in three groups: 10 patients with ten complication free years after EVAR or sac regression, 10 patients with endoleak type I and 10 patients with endoleak type II. It is investigated whether MRI can provide extra information for the detection of endoleaks after EVAR.

Magnetic resonance imaging (with PROUD software)

Intervention Type DEVICE

Philips Ingenia 3.0T MR system with in-house developed PROUD software

Interventions

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Magnetic resonance imaging (with PROUD software)

Philips Ingenia 3.0T MR system with in-house developed PROUD software

Intervention Type DEVICE

Other Intervention Names

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4D flow MRI DCE-MRI

Eligibility Criteria

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Inclusion Criteria

* diagnosed with AAA
* provision of written informed consent

* maximum AAA diameter between 3-5 cm
* not scheduled for aneurysm repair at the time of inclusion

* planned for elective EVAR

* ten complication free years after EVAR or sac regression after EVAR; or
* type I endoleak after EVAR; or
* type II endoleak after EVAR;

Exclusion Criteria

* Supra- or pararenal AAA
* Inflammatory, infectious or mycotic AAA
* Vasculitis and connective tissue disease
* Patients that underwent open surgical repair for their AAA
* Patients with ruptured AAAs
* Patients that previously presented with allergic reactions to intravenous contrast agents

* previous AAA repair
* severely reduced renal function
* previous allergic reactions to intravenous contrast agents

* previous AAA repair

* severely reduced renal function
* previous allergic reactions to intravenous contrast agents

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No