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
NCT ID: NCT00296855
Last Updated: 2010-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
261 participants
INTERVENTIONAL
2006-02-28
2007-02-28
Brief Summary
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Detailed Description
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Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Arm 1
Vasovist (BAY86-5283, MS-325)
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
Interventions
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Vasovist (BAY86-5283, MS-325)
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
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer Schering Pharma AG
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Buenos Aires, Buenos Aires, Argentina
Lornas de Zamora, Buenos Aires, Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Sankt Pölten, Lower Austria, Austria
Graz, Styria, Austria
Vienna, Vienna, Austria
Vienna, Vienna, Austria
Curitiba, Paraná, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Hamburg, City state of Hamburg, Germany
Frankfurt am Main, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Bonn, North Rhine-Westphalia, Germany
Cologne, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Mainz, Rhineland-Palatinate, Germany
Berlin, State of Berlin, Germany
Monterrey, Nuevo León, Mexico
Mexico D. F., , Mexico
México D.F., , Mexico
Basel, Basel, Switzerland
Baden, , Switzerland
Countries
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Other Identifiers
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EudraCT No. 2005-002547-66
Identifier Type: -
Identifier Source: secondary_id
308861
Identifier Type: -
Identifier Source: secondary_id
91463
Identifier Type: -
Identifier Source: org_study_id
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