NCT01589042已完成不适用
Chocolate Balloon Angioplasty Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 490
- 试验地点
- 13
- 主要终点
- Achievement of Optimal PTA
研究概览
简要总结
To collect data from real-world use with the Chocolate PTA Balloon Catheter to support the effectiveness of the device for use during percutaneous transluminal angioplasty (PTA) procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •>18 years of age
- •Lesion successfully crossed with a guide-wire
- •Reference Vessel Diameter (RVD) within the treatment range of the Chocolate PTA Catheter used at the target lesion appropriate for 1:1 dilatation
- •Patient has given consent for their information to be submitted to this registry
排除标准
- •Lesion required stenting as the primary treatment approach
- •Life expectancy <12 months
- •Patient is enrolled in another clinical study that may impact the results of this registry
结局指标
主要结局
Achievement of Optimal PTA
时间窗: average of 2 hours
Percentage of PTA cases in which \<30% diameter stenosis without a flow limiting dissection is achieved without the need for bail-out stenting
次要结局
未报告次要终点
研究者
研究点 (13)
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