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Vasovist Endoleak Study

This study has been completed.
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00483665
First received: June 6, 2007
Last updated: November 17, 2008
Last verified: November 2008
History of Changes

June 6, 2007
November 17, 2008
June 2006
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Complete list of historical versions of study NCT00483665 on ClinicalTrials.gov Archive Site
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Vasovist Endoleak Study
Detection of Endoleak by Vasovist-Enhanced Magnetic Resonance Imaging

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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
Abdominal Aortic Aneurysm
  • Procedure: Computed tomography angiography
    Computed tomography angiography
  • Procedure: Magnetic resonance imaging
    Magnetic resonance imaging after injection of Vasovist
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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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:

  • 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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00483665
UMC_06_112
No
M. Prokop, UMC Utrecht
UMC Utrecht
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Principal Investigator: Mathias Prokop, MD PhD UMC Utrecht
UMC Utrecht
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP