Angiography, Digital Subtraction, Magnetic Resonance Angiography
Conditions
Keywords
MRA, DSA, gadovist, angiography
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, image quality, and diagnostic confidence between a CE-MRA based diagnosis and the diagnosis achieved from the comparator procedure IA DSA using Ultravist.
Interventions
PROCEDURECE-MRA
Sponsors
National Taiwan University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of agreement | — |
| Image quality | — |
| Diagnostic confidence | — |
Countries
Taiwan
Contacts
Primary ContactHon-Man Liu, MD
Outcome results
None listed