Crossover Study With MultiHance vs a Comparator for Peripheral MRA

NCT ID: NCT00408083

Last Updated: 2009-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Peripheral Vascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

MultiHance MRI contrast agent

Group Type EXPERIMENTAL

MultiHance

Intervention Type DRUG

0.5 mmol/kg as a single dose administration

2

Magnevist contrast agent for MRA

Group Type ACTIVE_COMPARATOR

Magnevist

Intervention Type DRUG

0.5 mmol/kg as a single dose administration

Interventions

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MultiHance

0.5 mmol/kg as a single dose administration

Intervention Type DRUG

Magnevist

0.5 mmol/kg as a single dose administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bracco Diagnostics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Bracco Diagnostics, Inc.

Principal Investigators

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Gianpaolo Pirovano, MD

Role: STUDY_DIRECTOR

Bracco Diagnostics, Inc

Locations

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Bracco Imaging

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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MH 127

Identifier Type: -

Identifier Source: org_study_id

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