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Crossover Study With MultiHance vs a Comparator for Peripheral MRA

Information source: Bracco Diagnostics, Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Peripheral Vascular Disease

Intervention: MultiHance (Drug); Magnevist (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bracco Diagnostics, Inc

Official(s) and/or principal investigator(s):
Gianpaolo Pirovano, MD, Study Director, Affiliation: Bracco Diagnostics, Inc

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.

Clinical Details

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

Primary outcome: Assessment of global paired diagnostic preference of the two MRA exams

Secondary outcome: 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Bracco Imaging, Milan 20134, Italy
Additional Information

Starting date: December 2006
Last updated: March 25, 2009

Page last updated: August 23, 2015

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