A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR) Angiography

Guerbet

Status and phase: Completed; Phase 4

Conditions: Arterial Occlusive Disease

Treatments: Drug: gadoteric acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00447889

DGD-44-042

Details and patient eligibility

About

This is a clinical study of gadoteric acid in non-coronary MR angiography.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.