Crossover Study With MultiHance vs a Comparator for Peripheral MRA

Bracco Diagnostics, Inc100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Enrollment

100

Conditions

Peripheral Vascular Disease

Interventions

MultiHanceDRUG

0.5 mmol/kg as a single dose administration

MagnevistDRUG

0.5 mmol/kg as a single dose administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Bracco Imaging

Milan, Italy

Outcomes

Primary Outcomes

Assessment of global paired diagnostic preference of the two MRA exams

Time frame: Post dose

Secondary Outcomes

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

Time frame: post dose

Data from ClinicalTrials.gov

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