Trial Condition(s):
Cardiovascular Abnormalities
Magnevist® Injection enhanced MRA compared to non contrast MRA for the detection of structural abnormalities of the aortic arch and cerebral branches
Bayer Identifier:
90941
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the aortic arch and cerebral branches. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.
Inclusion Criteria
- Has known or suspected disease of the aortic arch and cerebral branches - Is scheduled for X-ray angiography
Exclusion Criteria
- Has any contraindication to magnetic resonance imaging - Is scheduled for any procedure before the X-ray angiography - Had previous bilateral intervention (surgery, bypass) of the arteries of interest
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations |
|---|
Trial Design
Multicenter, open-label study of the safety (open-label) and efficacy (open-label and blinded reader) of a single administration of approximately 0.1 mmol/kg of Magnevist® Injection-enhanced magnetic resonance arteriography (MRA) and 2-dimensional-time-of-flight (2D-TOF) MRA in patients with known or suspected disease of the aortic arch and cerebral branches who are undergoing MRA of these vessels with intra-arterial digital subtraction arteriography (i.a. DSA) as the standard of reference.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Accuracy, sensitivity, and specificity based on quantitative assessment of stenosis assesses by blinded readerTimeframe: Image creation after injection -evaluation at blind read
Secondary Outcome
- Diagnostic confidenceTimeframe: At blinded and/or open label read of the images
- Visual assessment of stenosisTimeframe: At blinded and/or open label read of the images
- Difference in degree of stenosisTimeframe: At blinded and/or open label read of the images
- Other diagnostic findingsTimeframe: At blinded and/or open label read of the images
- Location and matching of stenosisTimeframe: At blinded and/or open label read of the images
- Image qualityTimeframe: At blinded and/or open label read of the images
- Image evaluability and presence of artifactsTimeframe: At blinded and/or open label read of the images
- Ability to visualize arterial segmentsTimeframe: At blinded and/or open label read of the images
- Proportion of correctly categorized maximum stenosis per segmentTimeframe: At blinded and/or open label read of the images
- Number of evaluable segmentsTimeframe: At blinded and/or open label read of the images
- Duration if 2D TOF and CE-MRATimeframe: At blinded and/or open label read of the images
- Patient managementTimeframe: From baseline to 24 hours follow-up
- Safety variablesTimeframe: From baseline to 24 hours follow-up
Additional Information
Copyright © Bayer
Powered by
