A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title|
- Subject level efficacy of CE-MRA in detecting stenosis (50% occlusion) of major renal arteries. IA-DSA is the truth standard.
- Subject and vessel level efficacy comparison of CE-MRA and TOF-MRA in detecting stenosis, accessing arteries and diagnosis; Efficacy of CE-MRA and TOF-MAR combined; Clinical utility; Safety
|Study Start Date:||September 2003|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209391
|Amersham Buchler GmbH & Co. KG|
|Study Director:||Michael Karl, PhD||GE Healthcare|