Magnevist® Injection-enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis of the Renal Arteries

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Renal Artery Stenosis

Intervention / Treatment
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* Drug: Gadopentetate dimeglumine (Magnevist)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Gadopentetate dimeglumine (Magnevist)<br>* Approximately 0.1mmol/kg body weight, single intravenous administration on the study day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy, sensitivity and specificity based on quantitative assessment of stenosis |  | Image creation after injection - evaluation at blind read | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic confidence |  | At blinded and/or open label read of images | 
| Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses |  | At blinded and/or open label read of images | 
| Difference in degree of stenosis |  | At blinded and/or open label read of images | 
| Other diagnostic findings |  | At blinded and/or open label read of images | 
| Localisation matching of maximum stenosis |  | At blinded and/or open label read of images | 
| Image quality |  | At blinded and/or open label read of images | 
| Image evaluability and presence of artifacts |  | At blinded and/or open label read of images | 
| Proportions of correctly categorised arteries with regard to maximum stenosis |  | At blinded and/or open label read of images | 
| Number of evaluable arteries |  | At blinded and/or open label read of images | 
| Patient management |  | From baseline to 24 hours follow-up | 
| Safety |  | From baseline to 24 hours follow-up |