Status:
UNKNOWN
CE-MRA Using Gadovist in Comparison to IA DSA Using Ultravist
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Angiography, Digital Subtraction
Magnetic Resonance Angiography
Eligibility:
All Genders
20-75 years
Phase:
PHASE4
Brief Summary
This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced magnetic resonance angiography (CE-MRA) of the arteries.
Detailed Description
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, imag...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00154648
Start Date
June 1 2005
Last Update
June 5 2007
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan