Vasovist Endoleak Study

NCT ID: NCT00483665

Last Updated: 2008-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Brief Summary

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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

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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.

Conditions

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Abdominal Aortic Aneurysm

Keywords

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endoleak

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Computed tomography angiography

Computed tomography angiography

Intervention Type PROCEDURE

Magnetic resonance imaging

Magnetic resonance imaging after injection of Vasovist

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

INDUSTRY

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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UMC Utrecht

Principal Investigators

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Mathias Prokop, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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UMC Utrecht

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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UMC_06_112

Identifier Type: -

Identifier Source: org_study_id