Crossover Study With MultiHance vs a Comparator for Peripheral MRA
Information source: Bracco Diagnostics, Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peripheral Vascular Disease
Intervention: MultiHance (Drug); Magnevist (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bracco Diagnostics, Inc Official(s) and/or principal investigator(s): Gianpaolo Pirovano, MD, Study Director, Affiliation: Bracco Diagnostics, Inc
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 steno-occlusive disease.
Clinical Details
Official title: A Phase IIIB, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.1 Mmol/kg of Multihance With 0.1 Mmol/kg of Magnevist for Contrast-Enhanced Magnetic Resonance Angiography(CE-MRA) of Peripheral Arteries
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Primary outcome: Assessment of global paired diagnostic preference of the two MRA exams
Secondary outcome: To compare the two different products for signal intensity enhancement; average quality of visualization; technical failure rate; to assess inter-reader agreement in terms of average quality of visualization
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Bracco Imaging, Milan 20134, Italy
Additional Information
Starting date: December 2006
Last updated: March 25, 2009
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