drugset
drugset / Trial / NCT00209443

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

NCT00209443 ↗

Phase 3 Completed 407 enrolled GE Healthcare
Non-randomizedSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2004-09
Primary completion
2006-02-28
Completion
2006-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Gadodiamide Injection Unknown 0.1 mmol Intravenous

Indications

arterial occlusion