Vasovist Endoleak Study - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 6, 2007

Last Updated Date

November 17, 2008

Start Date ^†

June 2006

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00483665 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Vasovist Endoleak Study

Official Title ^†

Detection of Endoleak by Vasovist-Enhanced Magnetic Resonance Imaging

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 Phase

Study Type ^†

Observational

Study Design ^†

Case-Only, Prospective

Condition ^†

Abdominal Aortic Aneurysm

Intervention ^†

Procedure: Computed tomography angiography
Procedure: Magnetic resonance imaging

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Estimated Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

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.

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Netherlands

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00483665

Responsible Party

M. Prokop, UMC Utrecht

Secondary IDs ^††

Study Sponsor ^†

UMC Utrecht

Collaborators ^††

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Investigators ^†

Principal Investigator:

Mathias Prokop, MD PhD

UMC Utrecht

Information Provided By

UMC Utrecht

Verification Date

November 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.