Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis in the Calf and/or Pedal 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 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.

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 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.

Conditions
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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 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

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>* Gadopentetate dimeglumine (Magnevist Injection), 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 visual assessment of stenosis assesses by blinded reader |  | 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 the images | 
| Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by open label reader |  | 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 artefacts |  | At blinded and/or open label read of the images | 
| Ability to visualize arteries |  | At blinded and/or open label read of the images | 
| Exact categorization of stenosis |  | At blinded and/or open label read of the images | 
| Number of evaluable arteries |  | At blinded and/or open label read of the images | 
| Duration of 2D-TOF and MRA |  | At blinded and/or open label read of the images | 
| Artery appropriate for bypass |  | At blinded and/or open label read of the images | 
| Patient management |  | from baseline to 24 hours follow-up | 
| Safety |  | from baseline to 24 hours follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stenosis of the calf and/or pedal arteries