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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No. 2005-002547-66 | |||
| 308861 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasovist (BAY86-5283, MS-325) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic potential of Vasovist enhanced MRA | Imaging after baseline visit, before and after Vasovist injection |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the quantitative assessment and the qualitative assessment of arterial stenosis/disease as compared to X-ray angiography | After imaging | |
| Quantitative assessment of vessel enhancement | After imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | Buenos Aires | Argentina | ||||
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| Qualitative assessment of disease | After imaging |
| Qualitative assessment of plaque morphology | After imaging |
| Evaluation of quality of vascular anatomy and delineation of vessel wall, venous enhancement and diagnostic potential of venous enhancement | After imaging |
| Lornas de Zamora |
| Buenos Aires |
| B1832BQS |
| Argentina |
| Buenos Aires | Buenos Aires F.D. | C1082ACA | Argentina |
| Buenos Aires | Buenos Aires F.D. | C1428DDO | Argentina |
| Sankt Pölten | Lower Austria | 3100 | Austria |
| Vienna | State of Vienna | 1021 | Austria |
| Vienna | State of Vienna | 1090 | Austria |
| Graz | Styria | 8036 | Austria |
| Curitiba | Paraná | 80060-900 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 22649 | Brazil |
| São Paulo | São Paulo | 01323-001 | Brazil |
| São Paulo | São Paulo | 05403-900 | Brazil |
| Hamburg | Free and Hanseatic City of Hamburg | 20251 | Germany |
| Frankfurt am Main | Hesse | 60389 | Germany |
| Frankfurt am Main | Hesse | 60596 | Germany |
| Bonn | North Rhine-Westphalia | 53105 | Germany |
| Cologne | North Rhine-Westphalia | 50931 | Germany |
| Essen | North Rhine-Westphalia | 45147 | Germany |
| Münster | North Rhine-Westphalia | 48149 | Germany |
| Mainz | Rhineland-Palatinate | 55131 | Germany |
| Berlin | State of Berlin | 13353 | Germany |
| Monterrey | Nuevo León | 64460 | Mexico |
| Mexico D. F. | 06760 | Mexico |
| México D.F. | 10700 | Mexico |
| Basel | Basel | 4031 | Switzerland |
| Baden | 5404 | Switzerland |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| C109932 | gadofosveset trisodium |
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