NCT00309075已完成3 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 126
- 主要终点
- Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by blinded reader
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 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.
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
- Non Randomized
- 干预模型
- Single Group
- 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 disease of the calf and/or pedal arteries
- •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 calf and/or foot arteries
研究组 & 干预措施
Arm 1
Experimental
干预措施: Gadopentetate dimeglumine (Magnevist) (Drug)
结局指标
主要结局
Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses by blinded reader
时间窗: Image creation after injection - evaluation at blind read
次要结局
- 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)
- 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)
- Image quality(At blinded and/or open label read of the images)
- Diagnostic confidence(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)
研究者
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