Crossover Study With MultiHance vs a Comparator for Peripheral MRA

Phase 3

Completed

• Conditions: Peripheral Vascular Disease
• Interventions: Drug: MultiHance; Drug: Magnevist

• 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

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-04
• Study First Submitted QC: 2006-12-04
• Study First Posted: 2006-12-06
• Primary Completion: 2008-11
• Study Completion: 2008-12
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-25
• Last Update Posted: 2009-03-27

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