Crossover Study With MultiHance vs a Comparator for Peripheral MRA
NCT ID: NCT00408083
Last Updated: 2009-03-27
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
100 participants
INTERVENTIONAL
2006-12-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
QUADRUPLE
Study Groups
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1
MultiHance MRI contrast agent
MultiHance
0.5 mmol/kg as a single dose administration
2
Magnevist contrast agent for MRA
Magnevist
0.5 mmol/kg as a single dose administration
Interventions
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MultiHance
0.5 mmol/kg as a single dose administration
Magnevist
0.5 mmol/kg as a single dose administration
Eligibility Criteria
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Inclusion Criteria
* At least 18 yrs of age
* Moderate to severe peripheral arterial disease
* Willing to undergo two MRA procedures within 14 days
Exclusion Criteria
* Known allergies to one or more ingredients in the products
* Therapeutic intervention in the arterial territory of interest between the two MRA exams
* Changes in symptoms between the two exams
* Vascular stent in area of interest
* Severe claustrophobia
* Congestive heart failure class IV
* Scheduled to undergo surgery for PAOD between the two exams
* Scheduled to undergo DSA between the two exams
18 Years
ALL
No
Sponsors
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Bracco Diagnostics, Inc
INDUSTRY
Responsible Party
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Bracco Diagnostics, Inc.
Principal Investigators
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Gianpaolo Pirovano, MD
Role: STUDY_DIRECTOR
Bracco Diagnostics, Inc
Locations
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Bracco Imaging
Milan, , Italy
Countries
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Other Identifiers
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MH 127
Identifier Type: -
Identifier Source: org_study_id
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