NCT01014377已完成不适用
Assessment of the Safety of the VascuActive™ Device and Its Preliminary Efficacy on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With Peripheral Vascular Disease and Limb Ischemia
VascuActive LTD1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pain-free and Maximal walking distance
研究概览
简要总结
The purpose of this study is to assess the safety and the immediate effect of the VascuActive device on patients with peripheral vascular disease and limb ischemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Leg Ischemia, Fontaine grade IIa and IIb, i.e.: pain free walking distance in the range of 50 - 100 meters.
- •Absent pulses in the two foot arteries (Anterior Tibial a., Posterior Tibial a.)
- •ABI < 0.7 by Doppler, in at least one of the two foot arteries
排除标准
- •Absent femoral pulses
- •Venous insufficiency by Duplex
- •Pregnancy
- •Infectious disease
- •Malignant disease
- •Severe cardiac disease, e.g., CHF grade 3 or higher
- •Acute MI within last 3 months
- •CABG within last 3 months
- •Other severe systemic disease
结局指标
主要结局
Pain-free and Maximal walking distance
时间窗: 1 hour
次要结局
- Skin temperature(1 hour)
- Skin blood flow(1 hour)
- Transcutaneous partial pressure of O2 and CO2(1 hour)
研究者
研究点 (1)
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