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.
GEHC has decided not to provide this detail
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
407
Amersham Buchler GmbH & Co. KG
Ismaning, Germany
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.
Time frame: 27 hours
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
Time frame: 27 hours
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