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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00447889
Recruitment Status : Completed
First Posted : March 15, 2007
Last Update Posted : November 26, 2008
Information provided by:

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

Condition or disease Intervention/treatment Phase
Arterial Occlusive Disease Drug: gadoteric acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR)
Study Start Date : March 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00447889

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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
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Study Chair: Corinne Dubourdieu, PhD Guerbet
Layout table for additonal information Identifier: NCT00447889    
Other Study ID Numbers: DGD-44-042
First Posted: March 15, 2007    Key Record Dates
Last Update Posted: November 26, 2008
Last Verified: November 2008
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases