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Crossover Study With MultiHance vs a Comparator for Peripheral MRA

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ClinicalTrials.gov Identifier: NCT00408083
Recruitment Status : Completed
First Posted : December 6, 2006
Last Update Posted : March 27, 2009
Sponsor:
Information provided by:
Bracco Diagnostics, Inc

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.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Drug: MultiHance Drug: Magnevist Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : December 2006
Primary Completion Date : November 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
MultiHance MRI contrast agent
Drug: MultiHance
0.5 mmol/kg as a single dose administration
Active Comparator: 2
Magnevist contrast agent for MRA
Drug: Magnevist
0.5 mmol/kg as a single dose administration



Primary Outcome Measures :
  1. Assessment of global paired diagnostic preference of the two MRA exams [ Time Frame: Post dose ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408083


Locations
Italy
Bracco Imaging
Milan, Italy, 20134
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Gianpaolo Pirovano, MD Bracco Diagnostics, Inc

Responsible Party: Gianpaolo Pirovano, M.D. Executive Director, Corporate Medical Development, Bracco Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT00408083     History of Changes
Other Study ID Numbers: MH 127
First Posted: December 6, 2006    Key Record Dates
Last Update Posted: March 27, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases