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Crossover Study With MultiHance vs a Comparator for Peripheral MRA

This study has been completed.
Sponsor:
Information provided by:
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00408083
First received: December 4, 2006
Last updated: March 25, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
Peripheral Vascular Disease
 Drug: MultiHance
Drug: Magnevist
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Assessment of global paired diagnostic preference of the two MRA exams [ Time Frame: Post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2006
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408083

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

No publications provided

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
Study First Received: December 4, 2006
Last Updated: March 25, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on May 23, 2013