NCT00631540已完成不适用
REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Primary Patency of the Treated Renal Artery
研究概览
简要总结
The purpose of the study is to evaluate the safety and effectiveness of the Formula Balloon-Expandable Stent in treatment of renal artery stenosis.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •renal artery stenosis
- •appropriate size and location of the lesion
- •suboptimal angioplasty
排除标准
- •less than 18 years old
- •failure or inability to give informed consent
- •simultaneously participating in another drug or device study
研究组 & 干预措施
1
Experimental
renal artery stenting
干预措施: Formula Balloon-Expandable Stent (Device)
结局指标
主要结局
Primary Patency of the Treated Renal Artery
时间窗: 9 Months
Based on ultrasound images assessed by core lab.
次要结局
- 30-day Clinical Success(30 Days)
- Number of Participants With 30-day Major Adverse Events(30 Days)
- Number of Participants With 9-month Major Adverse Events(9 Months)
- Technical Success(Prior to Discharge)
- Acute Procedural Success(Prior to Discharge)
研究者
研究点 (7)
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