A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-Iliac 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 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.
|Aorto-Iliac Stenosis Arterial Occlusive Diseases||Drug: Gadodiamide Injection||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
- Differences in subject level and vessel level sensitivity and specificity between CE-MRA and TOF-MRA in detecting stenosis,(>50% occlusion) in aorto-iliac arteries. IA-DSA is the truth standard.
- Differences in sensitivity, specificity, accuracy, PPV and NPV at subject and/or vessel level between CE-MRA and TOF-MRA in detecting stenosis (50% occlusion) in aorta-iliac arteries; Revascularisation strategies based on CE-MRA, TOF-MRA and IA DSA
|Study Start Date:||September 2004|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209443
|Amersham Buchler GmbH & Co. KG|
|Study Director:||Michael Karl||GE Healthcare|