New MRI Techniques for Diagnosis and Treatment of Abdominal Aortic Aneurysms

Abdominal Aortic Aneurysm Without Rupture Clinical Trial

— MARVY  

Official title:

Gamechanger: Development of MRI Based Endovascular Procedures for Vascular Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05976711
• Other study ID #: 2008987
• Status: Recruiting
• Start date: May 4, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: September 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm Without Rupture
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Rupture

Intervention

Device:
• Magnetic resonance imaging (with PROUD software)
Philips Ingenia 3.0T MR system with in-house developed PROUD software

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam	Noord-Holland

Sponsors (3)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Brightfish, Nano4Imaging GmbH

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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