Magnevist® Injection-enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis of the Renal Arteries
Phase 3
Completed
- Conditions
- Renal Artery Stenosis
- Interventions
- Registration Number
- NCT00310557
- Lead Sponsor
- Bayer
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Gadopentetate dimeglumine (Magnevist) -
- Primary Outcome Measures
Name Time Method Accuracy, sensitivity and specificity based on quantitative assessment of stenosis Image creation after injection - evaluation at blind read
- Secondary Outcome Measures
Name Time Method Localisation matching of maximum stenosis At blinded and/or open label read of images Difference in degree of stenosis At blinded and/or open label read of images Image evaluability and presence of artifacts At blinded and/or open label read of images Other diagnostic findings At blinded and/or open label read of images Image quality 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 Diagnostic confidence 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 Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses At blinded and/or open label read of images