Magnevist® Injection enhanced MRA compared to non contrast MRA for the detection of stenosis in the calf and/or pedal arteries
The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the calf and foot arteries. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.
- Has known or suspected disease of the calf and/or pedal arteries - Is scheduled for X-ray angiography
- Has any contraindication to magnetic resonance imaging - Is scheduled for any procedure before the X-ray angiography - Had previously had stents placed bilaterally in the calf and/or foot arteries
Multicenter, open-label study of the safety (open-label) and efficacy (open-label and blinded reader) of a single administration of approximately 0.1 mmol/kg of Magnevist® Injection-enhanced magnetic resonance arteriography (MRA) and 2-dimensional-time-of-flight (2D-TOF) MRA in patients with known or suspected disease of the calf and/or pedal arteries undergoing MRA of the calf and pedal arteries with intra-arterial digital subtraction arteriography (i.a. DSA) as the standard of reference.
Single Group Assignment