Crossover Study With MultiHance vs a Comparator for Peripheral MRA
- Registration Number
- NCT00408083
- Lead Sponsor
- Bracco Diagnostics, Inc
- 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 steno-occlusive disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 MultiHance MultiHance MRI contrast agent 2 Magnevist Magnevist contrast agent for MRA
- Primary Outcome Measures
Name Time Method Assessment of global paired diagnostic preference of the two MRA exams Post dose
- Secondary Outcome Measures
Name Time Method 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 post dose
Trial Locations
- Locations (1)
Bracco Imaging
🇮🇹Milan, Italy