ClinicalTrials.gg
CompletedNCT00483665Updated Nov 19, 2008

Vasovist Endoleak Study

An observational study in Abdominal Aortic Aneurysm, sponsored by UMC Utrecht. Completed at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2008-11-19.

Sponsored by UMC Utrecht · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Sex
All
01

Study summary

After endovascular treatment of an abdominal aortic aneurysm, lifelong imaging follow-up is needed to monitor the effectiveness of the treatment. One parameter in this follow-up is endoleak, which is leakage of blood into the aneurysm sac. The aim of this study is to investigate the value of magnetic resonance imaging using Vasovist as a contrast agent for the detection of endoleaks.

Read the detailed description

After endovascular abdominal aortic aneurysm repair, life-long follow-up is needed to monitor the effectiveness of exclusion of the aneurysm sac from blood flow. For this reason, aneurysm diameter and the presence of endoleaks is evaluated with computed tomographic (CT) angiography yearly after Endovascular Aneurysm Repair (EVAR).

The aim of this study is to investigate the value of magnetic resonance imaging using Vasovist as a contrast agent for the detection of endoleaks.

The advantages of magnetic resonance imaging with respect to CTA are no use of ionizing radiation, use of less nephrotoxic contrast agents.

02

Conditions studied

  • Abdominal Aortic Aneurysm

Keywords

  • endoleak
03

In context

Aortic Aneurysm, Abdominal

467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.

This study's planned enrollment of 20 is below the median of 165 across 217 observational studies indexed under Aortic Aneurysm, Abdominal.

Browse Aortic Aneurysm, Abdominal studies →

Lead sponsor

UMC Utrecht is the lead sponsor of 364 studies on the registry; 82 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients after more than 1 year who have a stable or growing aneurysm according to diameters measured on CT angiography images and no evidence of endoleak on recent CT angiography

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient is more than one year after endovascular abdominal aortic aneurysm repair
  • Patient has a stable or growing aneurysm according to diameters measured on CT angiography images
  • No evidence of endoleak on recent CT angiography

Exclusion criteria

Exclusion Criteria:

  • for MRI examination

    • claustrophobia
    • pacemaker
    • other non-MRI compatible implants
  • contraindication for use of contrast agent

    • known allergy to drugs or contrast media
    • MRI examination with the use of gadolinium within 24 hours of the blood-pool agent injection
    • severe renal impairment = creatine > 2 mg/dl (=176 mmol/l)
    • patient clinically instable
    • Participation in drug research within 30 days before and 1 day after MRI-examination with use of Vasovist.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)

Interventions

  • ProcedureComputed tomography angiography

    Computed tomography angiography

  • ProcedureMagnetic resonance imaging

    Magnetic resonance imaging after injection of Vasovist

06

Study locations

1 site
  • UMC Utrecht
    Utrecht, 3584 CX, Netherlands
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00483665
Lead sponsor
UMC Utrecht
Collaborators
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
First posted
Jun 7, 2007
Start date
Jun 2006
Last update
Nov 19, 2008

Study contacts

Mathias Prokop, MD PhD
principal investigator · UMC Utrecht

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

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