This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced Magnetic Resonance Angiography (CE-MRA) of arteries.

Condition	Intervention	Phase
Angiography, Digital Subtraction Magnetic Resonance Angiography	Procedure: CE-MRA	Phase IV

Further Study Details: 

Primary Outcomes: -Rate of Agreement; -Image quality; -Diagnostic confidence
Expected Total Enrollment:  40

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 i.a. DSA using Ultravist.

Ages Eligible for Study:  20 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• i. With suspected or known disease of arteries
• ii. Scheduled for an i.a. DSA/ cut film angiography of arteries in a period less than 7 days prior to or after the study period and has completed delineation and documentation of all vessels.
• iii. Be willing and able to continue study participation. This included the administration of Gadovist® 1.0 and completion of all procedures required by the study protocol
• iv. Patient between 20 and 75 years of age
• v. Be fully informed and had signed consent in advance

Exclusion Criteria:

• i. Patient is clinically unstable or whose clinical course during the 72 hours safety observation period was unpredictable
• ii. Patient with renal failure
• iii. Woman who is pregnant or of childbearing potential without having had a negative pregnancy test prior to enrollment (within 72h prior to CE-MRA)
• iv. Lactating woman
• v. Patient with any contra-indication to MRI examination and i.a.DSA.
• vi. 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 h after CE-MRA).
• vii. Patient is scheduled for surgery or other interventions within the 72 hours after the CE-MRA/ i.a. DSA or had any such procedure within 48 hours prior to the study CE-MRA/i.a. DSA.
• viii. Hypersensitivity to gadobutrol products
• ix. Patient has previously entered this study

Please refer to this study by ClinicalTrials.gov identifier  NCT00154648

Hon-man Liu, MD      23123456  Ext. 2570 

Taiwan
      National Taiwan University Hospital, Taipei,  Taiwan; Recruiting

Study chairs or principal investigators

Hon-man Liu, MD,  Principal Investigator,  National Taiwan University Hospital   

Study ID Numbers:  0941540200
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00154648
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13