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

Gamechanger: Development of MRI Based Endovascular Procedures for Vascular Surgery

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysm Without Rupture
• Intervention / Treatment: Device: Magnetic resonance imaging (with PROUD software)

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Amsterdam UMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with an AAA from the Amsterdam UMC

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Device: Magnetic resonance imaging (with PROUD software); Philips Ingenia 3.0T MR system with in-house developed PROUD software; Other Names: DCE-MRI; 4D flow MRI
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.	Device: Magnetic resonance imaging (with PROUD software); Philips Ingenia 3.0T MR system with in-house developed PROUD software; Other Names: DCE-MRI; 4D flow MRI
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.	Device: Magnetic resonance imaging (with PROUD software); Philips Ingenia 3.0T MR system with in-house developed PROUD software; Other Names: DCE-MRI; 4D flow MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surveillance: correlation between growth rate and MRI derived parameters	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.	1 year
EVAR planning: correlation between morphological parameters measured based on MRA and CTA	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.	half year
EVAR follow up: difference in MRI parameters between patients with endoleaks and without	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.	1 year

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Nano4Imaging GmbH; Brightfish

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2023
• Primary Completion (Actual): March 13, 2025
• Study Completion (Actual): June 12, 2025

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; DCE MRI; Abdominal Aortic Aneurysm; 4D flow MRI
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Aortic Diseases; Rupture; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 2008987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No