Trial Condition(s):
Renal Artery Stenosis
Magnevist® Injection-enhanced MRA compared to non contrast MRA for the detection of stenosis of the renal arteries
Bayer Identifier:
90940
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 renal 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 renal artery 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 |
|---|
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 renal artery disease undergoing MRA of the renal 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 quantitative assessment of stenosisTimeframe: Image creation after injection - evaluation at blind read
Secondary Outcome
- Diagnostic confidenceTimeframe: At blinded and/or open label read of images
- Accuracy, sensitivity, and specificity based on visual assessment of stenosis assessesTimeframe: At blinded and/or open label read of images
- Difference in degree of stenosisTimeframe: At blinded and/or open label read of images
- Other diagnostic findingsTimeframe: At blinded and/or open label read of images
- Localisation matching of maximum stenosisTimeframe: At blinded and/or open label read of images
- Image qualityTimeframe: At blinded and/or open label read of images
- Image evaluability and presence of artifactsTimeframe: At blinded and/or open label read of images
- Proportions of correctly categorised arteries with regard to maximum stenosisTimeframe: At blinded and/or open label read of images
- Number of evaluable arteriesTimeframe: At blinded and/or 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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