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OpenTrials
Completed

NCT Number: NCT05976711

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

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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Key information

Conditions

Abdominal Aortic Aneurysm Without Rupture Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed with AAA
  • provision of written informed consent

Inclusion criteria

for surveillance part:

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

Inclusion criteria

for planning part:

  • planned for elective EVAR

Inclusion criteria

for follow-up part:

  • 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

Exclusion criteria

for surveillance part:

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

Exclusion criteria

for planning part:

  • previous AAA repair

Exclusion criteria

for follow-up part:

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

Treatment and study plan

Magnetic resonance imaging (with PROUD software)

Device

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

Other names: 4D flow MRI, DCE-MRI

Primary outcomes

  1. Surveillance: correlation between growth rate and MRI derived parameters

    Time frame: 1 year

    The main study parameter for phase B1 (surveillance) is the correlation between growth rate of the AAA (determinant for the standard of care) and measured MRI parameters acquired with 4D flow MRI and DCE-MRI.

  2. EVAR planning: correlation between morphological parameters measured based on MRA and CTA

    Time frame: half year

    The main study parameter for phase B2 (EVAR planning) is the difference between anatomical measurements (lengths and diameters) based on both CTA and MRA. Several quantitative anatomical measurements will be utilised to assess the feasibility of MRA for planning of EVARs.

  3. EVAR follow up: difference in MRI parameters between patients with endoleaks and without

    Time frame: 1 year

    The main study parameter for phase B3 (EVAR follow-up) is the difference in MRI parameters measured post-operatively in patients with and without EVAR related complications.

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Brightfish
  • Nano4Imaging GmbH

Registry information

Official study title

Gamechanger: Development of MRI Based Endovascular Procedures for Vascular Surgery

Acronym: MARVY

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 4, 2023
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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