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 images upon application of a conventional extracellular contrast agent. A catheter angiography, which will be performed as a routine diagnostic procedure for vascular diseases, will serve as an evaluation standard.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
261
All patients receive a single IV bolus injection of Vasovist at a dose of 0,03 mmol/kg BW at a flowrate of 0,5 mL/sec, followed by a saline flush of at least 30 mL
Unnamed facility
Buenos Aires, Buenos Aires, Argentina
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Lornas de Zamora, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires F.D., Argentina
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Buenos Aires, Buenos Aires F.D., Argentina
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Sankt Pölten, Lower Austria, Austria
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Vienna, State of Vienna, Austria
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Vienna, State of Vienna, Austria
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Graz, Styria, Austria
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Curitiba, Paraná, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
...and 16 more locations
Diagnostic potential of Vasovist enhanced MRA
Time frame: Imaging after baseline visit, before and after Vasovist injection
Comparison of the quantitative assessment and the qualitative assessment of arterial stenosis/disease as compared to X-ray angiography
Time frame: After imaging
Quantitative assessment of vessel enhancement
Time frame: After imaging
Qualitative assessment of disease
Time frame: After imaging
Qualitative assessment of plaque morphology
Time frame: After imaging
Evaluation of quality of vascular anatomy and delineation of vessel wall, venous enhancement and diagnostic potential of venous enhancement
Time frame: After imaging
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