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Crossover Study With MultiHance vs a Comparator for Peripheral MRA

Primary Purpose

Peripheral Vascular Disease

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
MultiHance
Magnevist
Sponsored by
Bracco Diagnostics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peripheral Vascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bracco Imaging

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

MultiHance MRI contrast agent

Magnevist contrast agent for MRA

Outcomes

Primary Outcome Measures

Assessment of global paired diagnostic preference of the two MRA exams

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

Full Information

First Posted
December 4, 2006
Last Updated
March 25, 2009
Sponsor
Bracco Diagnostics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00408083
Brief Title
Crossover Study With MultiHance vs a Comparator for Peripheral MRA
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 Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bracco Diagnostics, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
MultiHance MRI contrast agent
Arm Title
2
Arm Type
Active Comparator
Arm Description
Magnevist contrast agent for MRA
Intervention Type
Drug
Intervention Name(s)
MultiHance
Intervention Description
0.5 mmol/kg as a single dose administration
Intervention Type
Drug
Intervention Name(s)
Magnevist
Intervention Description
0.5 mmol/kg as a single dose administration
Primary Outcome Measure Information:
Title
Assessment of global paired diagnostic preference of the two MRA exams
Time Frame
Post dose
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianpaolo Pirovano, MD
Organizational Affiliation
Bracco Diagnostics, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Bracco Imaging
City
Milan
ZIP/Postal Code
20134
Country
Italy

12. IPD Sharing Statement

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Crossover Study With MultiHance vs a Comparator for Peripheral MRA

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