Crossover Study With MultiHance vs a Comparator for Peripheral MRA - Full Text View

Sponsored by:	Bracco Diagnostics, Inc
Information provided by:	Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:	NCT00408083

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 III

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
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:

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Gadolinium DTPA

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
1: Experimental MultiHance MRI contrast agent	Drug: MultiHance 0.5 mmol/kg as a single dose administration
2: Active Comparator 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:	Bracco Diagnostics, Inc. ( Gianpaolo Pirovano, M.D. Executive Director, Corporate Medical Development )
Study ID Numbers:	MH 127
Study First Received:	December 4, 2006
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00408083 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Peripheral Vascular Diseases
Vascular Diseases

Additional relevant MeSH terms:

Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 01, 2009