CE-MRA Using Gadovist in Comparison to IA DSA Using Ultravist
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ClinicalTrials.gov Identifier: NCT00154648
Verified June 2005 by National Taiwan University Hospital. Recruitment status was: Recruiting
This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced magnetic resonance angiography (CE-MRA) of the arteries.
Condition or disease
Angiography, Digital SubtractionMagnetic Resonance Angiography
This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced Magnetic Resonance Angiography (CE-MRA) of arteries (specified vessel segments) by analyzing the rate of agreement, image quality, and diagnostic confidence between a CE-MRA based diagnosis and the diagnosis achieved from the comparator procedure IA DSA using Ultravist.
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Ages Eligible for Study:
20 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
With suspected or known disease of the arteries
Scheduled for an IA DSA/cut film angiography of the arteries in a period of less than 7 days prior to or after the study period and has completed delineation and documentation of all vessels.
Willing and able to continue study participation. This includes the administration of Gadovist® 1.0 and completion of all procedures required by the study protocol
Patient is between 20 and 75 years of age
Fully informed and has signed consent in advance
Patient is clinically unstable or his/her clinical course during the 72 hour safety observation period was unpredictable
Patient with renal failure
Woman who is pregnant or of childbearing potential without having had a negative pregnancy test prior to enrollment (within 72 hours prior to CE-MRA)
Patient with any contraindication to magnetic resonance imaging (MRI) examination and IA DSA.
Patient receives any investigational drug within 30 days prior to study entry or is planned to receive any other investigational drug during the safety follow-up (72 hours after CE-MRA).
Patient is scheduled for surgery or other interventions within the 72 hours after the CE-MRA/IA DSA or had any such procedure within 48 hours prior to the study CE-MRA/IA DSA.