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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 365
- 主要终点
- Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant disease
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has known or suspected peripheral vascular disease
- •Is scheduled for X-ray angiography
排除标准
- •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
研究组 & 干预措施
Arm 1
干预措施: Gadopentetate dimeglumine (Magnevist, BAY86-4882) (Drug)
Arm 2
干预措施: Gadopentetate dimeglumine (Magnevist, BAY86-4882) (Drug)
结局指标
主要结局
Sensitivity, specificity and accuracy of the higher dose of Magnevist® Injection and 2D-TOF MRA for the detection of clinically significant disease
时间窗: Image creation after injection - evaluation at blind read
次要结局
- 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)