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

GEHC has decided not to provide this detail.

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.