Status:
COMPLETED
New MRI Techniques for Diagnosis and Treatment of Patients With Abdominal Aortic Aneurysms
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Brightfish
Nano4Imaging GmbH
Conditions:
Abdominal Aortic Aneurysm Without Rupture
Eligibility:
All Genders
18+ years
Brief 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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 4 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 12 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05976711
Start Date
May 4 2023
End Date
June 12 2025
Last Update
July 15 2025
Active Locations (1)
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1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105 AZ