Status:
COMPLETED
A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide
Lead Sponsor:
GE Healthcare
Conditions:
Aorto-iliac Stenosis
Arterial Occlusive Diseases
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 aorto-iliac 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 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2006
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT00209443
Start Date
September 1 2004
End Date
February 28 2006
Last Update
April 25 2019
Active Locations (1)
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1
Amersham Buchler GmbH & Co. KG
Ismaning, Germany