Vasovist Endoleak Study

UMC Utrecht

Status: Completed

Conditions: Abdominal Aortic Aneurysm

Treatments: Procedure: Computed tomography angiography; Procedure: Magnetic resonance imaging

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00483665

UMC_06_112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.