NCT00296855已完成3 期
Intra-individual Open-label Multicenter Comparison Study of Magnetic Resonance Angiography (MRA) With the Blood Pool Contrast Agent Vasovist® and a Conventional Extracellular Contrast Agent With Intra-arterial Digital Subtraction Angiography (i.a. DSA) in Patients With Peripheral Artery Disease
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
- 261
- 主要终点
- Diagnostic potential of Vasovist enhanced MRA
研究概览
简要总结
The particular aim of this study is the comparison of the diagnostic results of MRA images upon application of Vasovist (gadofosveset), a contrast agent not yet available on the market, with the MRA images upon application of a conventional extracellular contrast agent. A catheter angiography, which will be performed as a routine diagnostic procedure for vascular diseases, will serve as an evaluation standard.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany 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
- •Patients with a certain circulation disorder (aortoiliac disease Fontaine-stage IIb / IV) and an indication for the evaluation of the peripheral run-off arteries from the infrarenal aorta to the calves
- •Patients who are scheduled for X-ray angiography and magnetic resonance angiography (MRA) of the arteries mentioned above
- •Patients who have had a contrast-enhanced MRA examination of the arteries mentioned above using a standard extracellular contrast agent performed within 1 - 7 days prior to the study MRA examination
排除标准
- •Less than 18 years of age
- •Women who are pregnant, breast feeding or who are of childbearing potential and have not had a negative urine pregnancy test the same day as the study MRA examination
- •Requiring immediate therapy for their vascular disease or in whom conduct of all three angiographic procedures is not possible
- •Not being able to remain lying down for at least 45 - 60 min
- •Patients with a history of serious allergic reactions to any allergen including drugs and contrast agents or with a history of sickle cell disease or other hemolytic anemia
- •Having any contraindication to magnetic resonance imaging (MRI) examination or specifically for MRA (e.g. pacemaker, recent wound clips, and severe claustrophobia)
研究组 & 干预措施
Arm 1
Experimental
干预措施: Vasovist (BAY86-5283, MS-325) (Drug)
结局指标
主要结局
Diagnostic potential of Vasovist enhanced MRA
时间窗: Imaging after baseline visit, before and after Vasovist injection
次要结局
- Quantitative assessment of vessel enhancement(After imaging)
- Qualitative assessment of plaque morphology(After imaging)
- Comparison of the quantitative assessment and the qualitative assessment of arterial stenosis/disease as compared to X-ray angiography(After imaging)
- Qualitative assessment of disease(After imaging)
- Evaluation of quality of vascular anatomy and delineation of vessel wall, venous enhancement and diagnostic potential of venous enhancement(After imaging)
研究者
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