Abdominal Aortic Aneurysm Without RuptureMARVYNCT05976711
New MRI Techniques for Diagnosis and Treatment of Patients With Abdominal Aortic Aneurysms
An observational study of Abdominal Aortic Aneurysm Without Rupture, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm Without Rupture
- What is being tested?
- Magnetic resonance imaging (with PROUD software)
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 May 2023to 12 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an AAA from the Amsterdam UMC
Who may be able to join
- 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;
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Magnetic resonance imaging (with PROUD software)
- Keywords
- Abdominal Aortic Aneurysm, Magnetic Resonance Imaging, 4D flow MRI, DCE MRI
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (with PROUD software)Device
Also called 4D flow MRI, DCE-MRI
Philips Ingenia 3.0T MR system with in-house developed PROUD software
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Magnetic resonance imaging (with 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. Receives: Device: Magnetic resonance imaging (with 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. Receives: Device: Magnetic resonance imaging (with PROUD software) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start4 May 2023
- Primary completion13 Mar 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic Aneurysm Without RuptureStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Brightfish, Nano4Imaging GmbH
- Responsible party
- Principal investigator, Associate Prof. Dr. Kak Khee Yeung, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976711
- Sponsor's protocol ID
- 2008987
- Acronym
- MARVY
- Status last verified
- Apr 2025
- First submitted
- 26 Jul 2023
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aalbregt E, Stehling W, Nederveen A, van Helvoirt J, van Ooij P, Schrauben EM, Jongkind V, Yeung KK. Non-Contrast Magnetic Resonance Angiography for Endovascular Aneurysm Repair Planning in Abdominal Aortic Aneurysms: Acquisition Development and Comparison to Contrast-Enhanced Computed Tomography Angiography. J Endovasc Ther. 2026 Aug 21:15266028261474370. doi: 10.1177/15266028261474370. Online ahead of print.
PubMed 42629616
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamechanger: Development of MRI Based Endovascular Procedures for Vascular Surgery
- ClinicalTrials.gov ID
- NCT05976711
- Acronym / sponsor ID
- MARVY / 2008987
- Keywords
- Abdominal Aortic Aneurysm, Magnetic Resonance Imaging, 4D flow MRI, DCE MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Brightfish, Nano4Imaging GmbH
- Study start
- 4 May 2023 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surveillance | – | Device: Magnetic resonance imaging (with PROUD software)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). |
| EVAR planning | – | Device: Magnetic resonance imaging (with PROUD software)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. |
| EVAR follow-up | – | Device: Magnetic resonance imaging (with PROUD software)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an AAA from the Amsterdam UMC
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imaging (with PROUD software)Also: 4D flow MRI, DCE-MRIPhilips Ingenia 3.0T MR system with in-house developed PROUD software | Device | EVAR follow-up, EVAR planning, Surveillance |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Derived from this study: PubMed 42629616Aalbregt E, Stehling W, Nederveen A, van Helvoirt J, van Ooij P, Schrauben EM, Jongkind V, Yeung KK. Non-Contrast Magnetic Resonance Angiography for Endovascular Aneurysm Repair Planning in Abdominal Aortic Aneurysms: Acquisition Development and Comparison to Contrast-Enhanced Computed Tomography Angiography. J Endovasc Ther. 2026 Aug 21:15266028261474370. doi: 10.1177/15266028261474370. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm Without Rupture, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surveillance: correlation between growth rate and MRI derived parameters (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05976711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.