Vasovist Endoleak Study

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Vasovist Endoleak Study

Official Title

Detection of Endoleak by Vasovist-Enhanced Magnetic Resonance Imaging

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.

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.

Study Type

Observational

Condition

Abdominal Aortic Aneurysm

Intervention

Computed tomography angiography

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

20

Start Date

June 2006

Eligibility 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.

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Mathias Prokop, MD PhD, ,

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT00483665

Organization ID

UMC_06_112

Study Sponsor

UMC Utrecht

Collaborators

 Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Study Sponsor

Mathias Prokop, MD PhD, Principal Investigator, UMC Utrecht

Verification Date

November 2008