A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide

Inclusion Criteria: Study Subjects must be adults with confirmed or suspected Renal Artery stenosis. The subject must have been referred for Digital Subtraction Angiography. Exclusion Criteria: The subject has a known hypersensitivity to either conventional X-ray or gadolinium-based MR contrast media including, but not restricted to, the investigational product. The subject is lactating. The subject is pregnant as defined by a serum or urine β-HCG pregnancy test obtained within 24 hours before investigational product administration. The subject has received or is scheduled to receive MRI contrast medium within 24 h prior to or less than 24 hours after the investigational product administration. The subject has received or is scheduled to receive X-ray contrast medium within 7 days prior to or less than 24 hours after administration of investigational product. The subject has received an investigational product within 30 days prior to or will receive an investigational product less than 24 hours after investigational product administration. The subject has an active, serious, life-threatening disease with a life expectancy of less than 6 months. The subject has had a percutaneous transluminal angioplasty (PTA) in the renal region performed within 4 weeks prior to investigational product administration. The subject has a stent in the renal arteries. The subject has had a kidney transplantation. The subject has a serum creatinine value of >3.5 mg/dL (309.4 µmol/L). The subject has previously been included in this study. The subject has a contra-indication for MRI according to accepted clinical guidelines.