Vasovist Endoleak Study

Detection of Endoleak by Vasovist-Enhanced Magnetic Resonance Imaging

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00483665

Enrollment

Registered

2007-06-07

Start date

2006-06-30

Completion date

Unknown

Last updated

2008-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm

Keywords

endoleak

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.

Interventions

PROCEDUREComputed tomography angiography

Computed tomography angiography

PROCEDUREMagnetic resonance imaging

Magnetic resonance imaging after injection of Vasovist

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026