Status:
COMPLETED
Crossover Study With MultiHance vs a Comparator for Peripheral MRA
Lead Sponsor:
Bracco Diagnostics, Inc
Conditions:
Peripheral Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a double blind crossover study designed to compare two different gadolinium products given at the same dose to patients undergoing MRA assessment of lower legs for the evaluation of peripheral...
Eligibility Criteria
Inclusion
- Written informed consent
- At least 18 yrs of age
- Moderate to severe peripheral arterial disease
- Willing to undergo two MRA procedures within 14 days
Exclusion
- Pregnant or lactating
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00408083
Start Date
December 1 2006
End Date
December 1 2008
Last Update
March 27 2009
Active Locations (1)
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1
Bracco Imaging
Milan, Italy, 20134