Vasovist Endoleak Study - Full Text View

Sponsors and Collaborators:	UMC Utrecht Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by:	UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00483665

Purpose

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.

Condition	Intervention
Abdominal Aortic Aneurysm	Procedure: Computed tomography angiography Procedure: Magnetic resonance imaging

MedlinePlus related topics: Aneurysms CT Scans MRI Scans

Drug Information available for: Gadofosveset trisodium

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Detection of Endoleak by Vasovist-Enhanced Magnetic Resonance Imaging

Further study details as provided by UMC Utrecht:

Estimated Enrollment:	20
Study Start Date:	June 2006

Intervention Details:

Computed tomography angiography

Magnetic resonance imaging after injection of Vasovist

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients after more than 1 year who have a stable or growing aneurysm according to diameters measured on CT angiography images and no evidence of endoleak on recent CT angiography

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483665

Locations

Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584 CX

Sponsors and Collaborators

UMC Utrecht

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Investigators

Principal Investigator:

Mathias Prokop, MD PhD

UMC Utrecht

More Information

Responsible Party:	UMC Utrecht ( M. Prokop )
Study ID Numbers:	UMC_06_112
Study First Received:	June 6, 2007
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00483665
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:

endoleak

Study placed in the following topic categories:

Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal

Abdominal aortic aneurysm
Vascular Diseases
Aortic Aneurysm

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009