NCT00209391

A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide

A Multicentre, Phase 3, Open-Label, Controlled Study Evaluating the Efficacy and Safety of 0.1 mmol/kg OMNISCAN (Gadodiamide Injection) in Magnetic Resonance Angiography (MRA) of the Renal Arteries

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 395 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 renal artery 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 renal arteries. Intra-arterial Digital Subtraction Angiography will be used as the standard of truth.

Detailed description

GEHC has decided not to provide this detail.

Conditions

• Renal Artery Stenosis

Interventions

Type	Name	Description
DRUG	Gadodiamide Injection

Timeline

• Start date: 2003-09-01
• Primary completion: 2005-08-01
• Completion: 2005-08-01
• First posted: 2005-09-21
• Last updated: 2019-04-25

Locations

1 site across 1 country: Germany