NCT01538108Unknown不适用
The Use of NMB Drug Ejecting Balloon for Arteriovenous (AV) Dialysis Fistulae
N.M.B. Medical Applications Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Restenosis Rate
研究概览
简要总结
The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) Balloon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 18 years and older
- •Patients with arteriovenous fistula with obstructive lesion
- •Patient who is willing and able to sign a written informed consent
排除标准
- •age < 18
- •female with child bearing potential
- •Previous participation in another study with any investigational drug or device within the past 30 days
- •Life expectancy of less than 12 months
结局指标
主要结局
Restenosis Rate
时间窗: 6 months
次要结局
- Restenosis rate(1,3 and 12 months)
- Easy insertion and removal(intraprocedural)
- Major adverse events(intraprocedural, 1, 3, 6 and 12 months)
研究者
研究点 (1)
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