Crossover Study With MultiHance vs a Comparator for Peripheral MRA

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bracco Diagnostics, Inc

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