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

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 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.

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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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

Conditions
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Peripheral Vascular Disease

Intervention / Treatment
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* Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)
* Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)


Participation Criteria
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Eligibility Criteria
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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

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)<br>* Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight<br>|
| Experimental: Arm 2<br> | Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)<br>* Single intravenous injection on the study day: higher dose corresponding approx. 0.2 - 0.3 mmol/kg body weight<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant disease |  | Image creation after injection - evaluation at blind read | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic confidence |  | At blinded or/and open label read of images | 
| Visual assessment of stenosis |  | At blinded or/and open label read of images | 
| Difference in degree of stenosis |  | At blinded or/and open label read of images | 
| Other diagnostic findings |  | At blinded or/and open label read of images | 
| Image quality |  | At blinded or/and open label read of images | 
| Image evaluability and presence of artifacts |  | At blinded or/and open label read of images | 
| Ability to visualize arterial segments |  | At blinded or/and open label read of images | 
| Number of evaluable segments |  | At blinded or/and open label read of images | 
| Location and matching of stenosis |  | At blinded or/and open label read of images | 
| SI measurements |  | At blinded or/and open label read of 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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Structural abnormalities of the infrarenal aorta and peripheral arteries