Status:
COMPLETED
Comparison Study of Vasovist® Magnetic Resonance Angiography (MRA) and an MRA With a Conventional Extracellular Contrast Agent With X-ray Angiography in Patients With Peripheral Artery Disease
Lead Sponsor:
Bayer
Conditions:
Peripheral Vascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The particular aim of this study is the comparison of the diagnostic results of MRA images upon application of Vasovist (gadofosveset), a contrast agent not yet available on the market, with the MRA i...
Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial...
Eligibility Criteria
Inclusion
- Patients with a certain circulation disorder (aortoiliac disease Fontaine-stage IIb / IV) and an indication for the evaluation of the peripheral run-off arteries from the infrarenal aorta to the calves
- Patients who are scheduled for X-ray angiography and magnetic resonance angiography (MRA) of the arteries mentioned above
- Patients who have had a contrast-enhanced MRA examination of the arteries mentioned above using a standard extracellular contrast agent performed within 1 - 7 days prior to the study MRA examination
Exclusion
- Less than 18 years of age
- Women who are pregnant, breast feeding or who are of childbearing potential and have not had a negative urine pregnancy test the same day as the study MRA examination
- Requiring immediate therapy for their vascular disease or in whom conduct of all three angiographic procedures is not possible
- Not being able to remain lying down for at least 45 - 60 min
- Patients with a history of serious allergic reactions to any allergen including drugs and contrast agents or with a history of sickle cell disease or other hemolytic anemia
- Having any contraindication to magnetic resonance imaging (MRI) examination or specifically for MRA (e.g. pacemaker, recent wound clips, and severe claustrophobia)
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT00296855
Start Date
February 1 2006
End Date
February 1 2007
Last Update
April 23 2010
Active Locations (26)
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1
Buenos Aires, Buenos Aires, Argentina
2
Lornas de Zamora, Buenos Aires, Argentina, B1832BQS
3
Buenos Aires, Buenos Aires F.D., Argentina, C1082ACA
4
Buenos Aires, Buenos Aires F.D., Argentina, C1428DDO