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NCT00483665 Clinical Trial

Vasovist Endoleak Study

Abdominal Aortic Aneurysm Clinical Trial

Official title:
Detection of Endoleak by Vasovist-Enhanced Magnetic Resonance Imaging

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00483665
Other study ID # UMC_06_112
Secondary ID
Status Completed
Phase N/A
First received June 6, 2007
Last updated November 17, 2008
Start date June 2006

Study information
Verified date November 2008
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Computed tomography angiography
Computed tomography angiography
• Magnetic resonance imaging
Magnetic resonance imaging after injection of Vasovist

Locations
Country Name City State
Netherlands UMC Utrecht Utrecht

Sponsors (2)
Lead Sponsor Collaborator
UMC Utrecht Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Country where clinical trial is conducted

Netherlands, 

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