Trial Condition(s):
Peripheral vascular disease
Magnevist® Injection enhanced MRA at two dose levels compared to non contrast MRA for the detection of structural abnormalities of the infrarenal aorta and peripheral arteries
Bayer Identifier:
91208
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 infrarenal aorta and peripheral arteries. 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 peripheral vascular disease - 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 previously had stents placed bilaterally in the region to be imaged
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations |
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Trial Design
Randomized, multi-center open label study of the safety (open-label) and efficacy (open-label & blinded reader) of Magnevist® Injection-enhanced magnetic resonance arteriography (MRA) at two dose levels and 2-dimensional-time-of-flight (2D-TOF) MRA in patients undergoing MRA of the infrarenal aorta and peripheral arteries with intra-arterial digital subtraction arteriography (i.a. DSA) as standard of reference
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant diseaseTimeframe: Image creation after injection - evaluation at blind read
Secondary Outcome
- Diagnostic confidenceTimeframe: At blinded or/and open label read of images
- Visual assessment of stenosisTimeframe: At blinded or/and open label read of images
- Difference in degree of stenosisTimeframe: At blinded or/and open label read of images
- Other diagnostic findingsTimeframe: At blinded or/and open label read of images
- Image qualityTimeframe: At blinded or/and open label read of images
- Image evaluability and presence of artifactsTimeframe: At blinded or/and open label read of images
- Ability to visualize arterial segmentsTimeframe: At blinded or/and open label read of images
- Number of evaluable segmentsTimeframe: At blinded or/and open label read of images
- Location and matching of stenosisTimeframe: At blinded or/and open label read of images
- SI measurementsTimeframe: At blinded or/and open label read of images
- Patient managementTimeframe: From baseline to 24 hours follow-up
- SafetyTimeframe: From baseline to 24 hours follow-up
Additional Information
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