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

Sponsored by:	Guerbet
Information provided by:	Guerbet
ClinicalTrials.gov Identifier:	NCT00447889

Purpose

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

Condition	Intervention	Phase
Arterial Occlusive Disease	Drug: gadoteric acid	Phase IV

Drug Information available for: Gadoteric acid

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR)

Further study details as provided by Guerbet:

Study Start Date:	March 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447889

Locations

Sponsors and Collaborators

Guerbet

Investigators

Study Chair:

Corinne Dubourdieu, PhD

Guerbet

More Information

Study ID Numbers:	DGD-44-042
Study First Received:	March 14, 2007
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00447889
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Arterial Occlusive Diseases
Vascular Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009