Trial Condition(s):
Stenosis
Magnevist® Injection enhanced MRA compared to non contrast MRA for the detection of stenosis in the calf and/or pedal arteries
Bayer Identifier:
91251
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 calf and foot 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 disease of the calf and/or pedal arteries - 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 calf and/or foot arteries
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
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 calf and/or pedal arteries undergoing MRA of the calf and pedal arteries 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 visual 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
- Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by open label readerTimeframe: 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 artefactsTimeframe: At blinded and/or open label read of the images
- Ability to visualize arteriesTimeframe: At blinded and/or open label read of the images
- Exact categorization of stenosisTimeframe: At blinded and/or open label read of the images
- Number of evaluable arteriesTimeframe: At blinded and/or open label read of the images
- Duration of 2D-TOF and MRATimeframe: At blinded and/or open label read of the images
- Artery appropriate for bypassTimeframe: At blinded and/or open label read of the images
- Patient managementTimeframe: from baseline to 24 hours follow-up
- SafetyTimeframe: from baseline to 24 hours follow-up
Additional Information
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