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 Type
Observational
Condition
Abdominal Aortic Aneurysm
Intervention
Computed tomography angiography
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
Procedure
Estimated Enrollment
20
Start Date
June 2006
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
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Mathias Prokop, MD PhD, ,
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT00483665
Organization ID
UMC_06_112
Study Sponsor
UMC Utrecht
Collaborators
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Study Sponsor
Mathias Prokop, MD PhD, Principal Investigator, UMC Utrecht
Verification Date
November 2008