NCT00483665

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2007

Completed
Last Updated

November 19, 2008

Status Verified

November 1, 2008

First QC Date

June 6, 2007

Last Update Submit

November 17, 2008

Conditions

Abdominal Aortic Aneurysm

Keywords

endoleak

Interventions

Computed tomography angiographyPROCEDURE

Computed tomography angiography

Magnetic resonance imagingPROCEDURE

Magnetic resonance imaging after injection of Vasovist

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • contraindication 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalEndoleak

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesPostoperative HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Mathias Prokop, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2007

First Posted

June 7, 2007

Study Start

June 1, 2006

Last Updated

November 19, 2008

Record last verified: 2008-11

Locations

NL(1)