CE-MRA Using Gadovist in Comparison to IA DSA Using Ultravist
NCT ID: NCT00154648
Last Updated: 2007-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2005-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Interventions
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CE-MRA
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
* Lactating woman
* 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.
* Hypersensitivity to gadobutrol products
* Patient has previously entered this study
20 Years
75 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Principal Investigators
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Hon-Man Liu, MD
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Hon-Man Liu, MD
Role: CONTACT
Facility Contacts
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Hon-Man Liu, MD
Role: primary
Other Identifiers
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0941540200
Identifier Type: -
Identifier Source: org_study_id