CE-MRA Using Gadovist in Comparison to IA DSA Using Ultravist

National Taiwan University

Status and phase: Unknown; Phase 4

Conditions: Magnetic Resonance Angiography; Angiography, Digital Subtraction

Treatments: Procedure: CE-MRA

Study type: Interventional

Funder types: Other

Identifiers

NCT00154648

0941540200

Details and patient eligibility

About

This trial is to show the diagnostic efficacy of Gadovist for contrast enhanced magnetic resonance angiography (CE-MRA) of the arteries.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)