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Crossover Study With MultiHance vs a Comparator for Peripheral MRA

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Bracco

Status and phase

Completed
Phase 3

Conditions

Peripheral Vascular Disease

Treatments

Drug: MultiHance
Drug: Magnevist

Study type

Interventional

Funder types

Industry

Identifiers

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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