A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide
Aorto-iliac Stenosis, Arterial Occlusive Diseases
About this trial
This is an interventional diagnostic trial for Aorto-iliac Stenosis focused on measuring Aorto-iliac Stenosis, Occlusion, Diagnostic Imaging, Omniscan, Magnetic Resonance Angiography, Contrast Media
Eligibility Criteria
Inclusion Criteria: Study subjects must be adults with confirmed or suspected aorto-iliac 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 beta-HCG pregnancy test obtained within 24 hours before administration of the investigational product. The subject received or is scheduled to receive MRI contrast medium within 24 hours prior to or less than 24 hours after administration of the investigational product. The subject received or is scheduled to receive X-ray contrast medium within 24 hours prior to or less than 24 hours after administration of the investigational product. The subject received an investigational product other than OMNISCAN (gadodiamide) within 30 days prior to OMNISCAN administration or will receive an investigational product within the follow-up period proposed for this study. The subject presents any clinically active, serious, life-threatening disease with a life expectancy of less than 6 months. 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. The subject has metal implants and/or stents in the aorto-iliac region and/or hip replacement.
Sites / Locations
- Amersham Buchler GmbH & Co. KG
Arms of the Study
Arm 1
Experimental
Gadodiamide Injection
All subjects received a single intravenous bolus injection via a power injector of Omniscan (Gadodiamide Injection) at a dose of 0.1 mmol/kg