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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
  Purpose

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.


Condition Intervention
Abdominal Aortic Aneurysm
 Procedure: Computed tomography angiography
Procedure: Magnetic resonance imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Detection of Endoleak by Vasovist-Enhanced Magnetic Resonance Imaging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Estimated Enrollment: 20
Study Start Date: June 2006
Intervention Details:
    Procedure: Computed tomography angiography
    Computed tomography angiography
    Procedure: Magnetic resonance imaging
    Magnetic resonance imaging after injection of Vasovist
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.

  Eligibility

Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483665

Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Investigators
Principal Investigator: Mathias Prokop, MD PhD UMC Utrecht
  More Information

No publications provided

Responsible Party: M. Prokop, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00483665     History of Changes
Other Study ID Numbers: UMC_06_112
Study First Received: June 6, 2007
Last Updated: November 17, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
endoleak

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Endoleak
Vascular Diseases
Cardiovascular Diseases
 Aortic Diseases
Postoperative Hemorrhage
Hemorrhage
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on May 22, 2013