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Completed

NCT Number: NCT00483665

Vasovist Endoleak Study

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computed Tomography Angiography

Procedure

Computed tomography angiography

Magnetic Resonance Imaging

Procedure

Magnetic resonance imaging after injection of Vasovist

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Registry information

Official study title

Detection of Endoleak by Vasovist-Enhanced Magnetic Resonance Imaging

Important dates

Study start
2006
First posted
Jun 7, 2007
Registry last updated
Nov 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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