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

This study has been completed.
Sponsor:
Information provided by:
Guerbet
ClinicalTrials.gov Identifier:
NCT00447889
First received: March 14, 2007
Last updated: November 25, 2008
Last verified: November 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Arterial Occlusive Disease
 Drug: gadoteric acid
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Guerbet
Investigators
Study Chair: Corinne Dubourdieu, PhD Guerbet
  More Information

No publications provided

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

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013