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Sponsored by: |
GE Healthcare |
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Information provided by: | GE Healthcare |
ClinicalTrials.gov Identifier: | NCT00209443 |
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 vessels throughout the body.
Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the aorto-iliac vessels using MR.
The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in aorto-iliac arteries. Intra-arterial Digital Subtraction Angiography (IADSA) will be used as the standard of truth.
Condition | Intervention | Phase |
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Aorto-Iliac Stenosis Arterial Occlusive Diseases |
Drug: Gadodiamide Injection |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 295 |
Study Start Date: | September 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SOV302 |
Study First Received: | September 13, 2005 |
Last Updated: | October 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00209443 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; European Union: European Medicines Agency |
Aorto-iliac Stenosis Occlusion Diagnostic Imaging |
Omniscan Magnetic Resonance Angiography Contrast Media |
Arterial Occlusive Diseases Vascular Diseases Constriction, Pathologic |
Cardiovascular Diseases |