NCT00447889CompletedPhase 4
A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Guerbet
- Locations
- 2
Study Overview
Brief Summary
This is a clinical study of gadoteric acid in non-coronary MR angiography.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Investigators
Study Sites (2)
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