Vasovist Endoleak Study

Completed

• Conditions: Abdominal Aortic Aneurysm

• Registration Number: NCT00483665
• Lead Sponsor: UMC Utrecht

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 Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-06-06
• Study First Submitted QC: 2007-06-06
• Study First Posted: 2007-06-07
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-17
• Last Update Posted: 2008-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands