Crossover Study With MultiHance vs a Comparator for Peripheral MRA

A Phase IIIB, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.1 Mmol/kg of Multihance With 0.1 Mmol/kg of Magnevist for Contrast-Enhanced Magnetic Resonance Angiography(CE-MRA) of Peripheral Arteries

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00408083

Enrollment

100

Registered

2006-12-06

Start date

2006-12-31

Completion date

2008-12-31

Last updated

2009-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Vascular Disease

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.

Interventions

DRUGMultiHance

0.5 mmol/kg as a single dose administration

DRUGMagnevist

0.5 mmol/kg as a single dose administration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Assessment of global paired diagnostic preference of the two MRA exams	Post dose

Secondary

Measure	Time frame
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026