Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Gadobenic acid
Gadolinium DTPA
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014