Magnevist® Injection Enhanced MRA at Two Dose Levels Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Infrarenal Aorta and Peripheral Arteries

Randomized, Multi-center Open Label Study of the Safety (Open-label) and Efficacy (Open-label & Blinded Reader) of Magnevist® Injection-enhanced Magnetic Resonance Arteriography (MRA) at Two Dose Levels and 2-dimensional-time-of-flight (2D-TOF) MRA in Patients Undergoing MRA of the Infrarenal Aorta and Peripheral Arteries With Intra-arterial Digital Subtraction Arteriography (i.a. DSA) as Standard of Reference

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 infrarenal aorta and peripheral arteries. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Inclusion Criteria:

• Has known or suspected peripheral vascular disease
• Is scheduled for X-ray angiography

Exclusion Criteria:

• 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 region to be imaged