Status:
COMPLETED
A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide
Lead Sponsor:
GE Healthcare
Conditions:
Renal Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial...
Detailed Description
GEHC has decided not to provide this detail.
Eligibility Criteria
Inclusion
- Study Subjects must be adults with confirmed or suspected Renal Artery stenosis.
- The subject must have been referred for Digital Subtraction Angiography.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
395 Patients enrolled
Trial Details
Trial ID
NCT00209391
Start Date
September 1 2003
End Date
August 1 2005
Last Update
April 25 2019
Active Locations (1)
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1
Amersham Buchler GmbH & Co. KG
Ismaning, Germany