NCT02396186已完成不适用
An Assessment of the Glider Balloon in Complex Lesions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Technical Success Rate
研究概览
简要总结
The purpose of this study is to collect data from real-world use with the Glider Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to support the effectiveness of the Glider PTCA Balloon for crossing into complex coronary lesions.
详细描述
Observational Study collecting data on commercial cases in which the Glider PTCA Balloon Catheter is used in accordance with the instructions for use. This study includes up 500 patients at up to 50 study sites.
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
- •Lesion must be successfully crossed with a guidewire without complication (including Chronic Total Occlusions (CTOs))
- •The Glider balloon may only be used at one lesion during the procedure
- •The lesion in which the Glider balloon is used must be completed first
- •The primary lesion treated during the procedure must be treated with the Glider balloon
- •Intended treatment of a protocol-defined complex lesion that has at least one of the following factors:
- •Significant vessel tortuosity
- •Failed balloon crossing with another balloon
- •Tight stenosis
- •Heavy calcification
- •Side branch present
排除标准
- •Patient < 18 years of age
- •Lesion longer than 40mm
- •Device use not consistent with Instructions for Use
- •Patient has not given consent for their data to be submitted to this registry
结局指标
主要结局
Technical Success Rate
时间窗: 1 hour
Percentage of lesions successfully crossed among those attempted with the Glider PTCA catheter.
次要结局
- Freedom from Balloon Slippage(1 hour)
- Lesion Success Rate(48 hours)
研究者
研究点 (4)
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