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
Phase 3
Completed
- Conditions
- Peripheral Vascular Disease
- Interventions
- Registration Number
- NCT00185276
- 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 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
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
- 365
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Gadopentetate dimeglumine (Magnevist, BAY86-4882) - Arm 1 Gadopentetate dimeglumine (Magnevist, BAY86-4882) -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Number of evaluable segments At blinded or/and open label read of images SI measurements At blinded or/and open label read of images Image quality At blinded or/and open label read of images Diagnostic confidence At blinded or/and open label read of images Ability to visualize arterial segments At blinded or/and open label read of images Visual assessment of stenosis At blinded or/and open label read of images Image evaluability and presence of artifacts At blinded or/and open label read of images Location and matching of stenosis 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