Crossover Study With MultiHance vs a Comparator for Peripheral MRA

Bracco

Status and phase: Completed; Phase 3

Conditions: Peripheral Vascular Disease

Treatments: Drug: MultiHance; Drug: Magnevist

Study type: Interventional

Funder types: Industry

Identifiers

NCT00408083

MH 127

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

1

Experimental group

Description:

MultiHance MRI contrast agent

Treatment:

Drug: MultiHance

2

Active Comparator group

Description:

Magnevist contrast agent for MRA

Treatment:

Drug: Magnevist