Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Aortic Arch and Cerebral Branches
Phase 3
Completed
- Conditions
- Cardiovascular Abnormalities
- Interventions
- Registration Number
- NCT00310609
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Gadopentetate dimeglumine (Magnevist) -
- Primary Outcome Measures
Name Time Method Accuracy, sensitivity, and specificity based on quantitative assessment of stenosis assesses by blinded reader Image creation after injection -evaluation at blind read
- Secondary Outcome Measures
Name Time Method Diagnostic confidence At blinded and/or open label read of the images Visual assessment of stenosis At blinded and/or open label read of the images Difference in degree of stenosis At blinded and/or open label read of the images Other diagnostic findings At blinded and/or open label read of the images Location and matching of stenosis At blinded and/or open label read of the images Image quality At blinded and/or open label read of the images Image evaluability and presence of artifacts At blinded and/or open label read of the images Ability to visualize arterial segments At blinded and/or open label read of the images Number of evaluable segments At blinded and/or open label read of the images Duration if 2D TOF and CE-MRA At blinded and/or open label read of the images Patient management From baseline to 24 hours follow-up Safety variables From baseline to 24 hours follow-up Proportion of correctly categorized maximum stenosis per segment At blinded and/or open label read of the images