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

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

Detailed Description
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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.

Official Title
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An Open, Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) Study of Arteries Using Gadovist 1.0 in Comparison to Intra-Arterial Digital Subtraction Angiography (IA DSA) Using Ultravist

Conditions
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Angiography, Digital Subtraction, Magnetic Resonance Angiography

Intervention / Treatment
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* Procedure: CE-MRA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: CE-MRA|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of agreement |  |  | 
| Image quality |  |  | 
| Diagnostic confidence |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRA, DSA, gadovist, angiography