Crossover Study With MultiHance vs a Comparator for Peripheral MRA

Peripheral Vascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408083
• Other study ID #: MH 127
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2006
• Last updated: March 25, 2009
• Start date: December 2006
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• MultiHance
0.5 mmol/kg as a single dose administration
• Magnevist
0.5 mmol/kg as a single dose administration

Locations

Country	Name	City	State
Italy	Bracco Imaging	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of global paired diagnostic preference of the two MRA exams		Post dose	No
Secondary	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		post dose	No