Status:
COMPLETED
A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR) Angiography
Lead Sponsor:
Guerbet
Conditions:
Arterial Occlusive Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a clinical study of gadoteric acid in non-coronary MR angiography.
Eligibility Criteria
Inclusion
- Male or female, at least the age of legal maturity
- Strongly suspected of having non-coronary arterial disease, detected clinically
- Scheduled to undergo x-ray angiography examination
- Female patients must be using effective contraception or be surgically sterilized or post-menopausal.
- Females of childbearing potential must have a documented negative urine pregnancy test.
Exclusion
- Contraindication to magnetic resonance imaging (MRI)
- Any metallic medical device in the vascular territory for which the patient is to undergo imaging examinations
- Congenital morphologic vascular abnormalities
- Known allergy to gadolinium chelates
- Pregnant, breast feeding, or planning to become pregnant during the trial
- Received a gadolinium complex within 2 days or iron oxide nanoparticles within 7 days before the gadoteric acid-enhanced magnetic resonance angiography (MRA) examination.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
November 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00447889
Start Date
March 1 2006
End Date
November 1 2007
Last Update
November 26 2008
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea