Crossover Study With MultiHance vs a Comparator for Peripheral MRA

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

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.

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