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A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide

Arterial Occlusive Diseases Clinical Trial

Official title:
A Multicentre, Phase 3, Open-Label Study to Assess the Efficacy and Safety of 0.1 mmol/kg Omniscan (Gadodiamide Injection) for Magnetic Resonance Angiography (MRA) of the Aorto-iliac Arteries

Clinical Trial Summary

Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body.

Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the aorto-iliac vessels using MR.

The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in aorto-iliac arteries. Intra-arterial Digital Subtraction Angiography (IADSA) will be used as the standard of truth.

Clinical Trial Description

GEHC has decided not to provide this detail ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00209443
Study type Interventional
Source GE Healthcare
Contact
Status Completed
Phase Phase 3
Start date September 2004
Completion date February 28, 2006
View Details
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