NL-OMON46231已完成不适用
First-in-Human for Fiber Optic RealShape (FORS) - FORS FIRST
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Philips
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age > 18 years.
- •Willingness to sign informed consent.
- •Scheduled for elective endovascular procedure either for stenotic or aneurysmatic pathology
- •Anatomical conformation suitable for the investigational medical devices (5.5 F 80cm Cobra C2 catheter, and/or 5.5F 80cm Berenstein catheter, and a 0.035* 120cm floppy guidewire)
排除标准
- •Intolerance to contrast media.
- •Emergency procedure.
- •Current participation in a concurrent trial that may confound study results.
- •Subjects unwilling or unable to comply with the protocol.
- •Subjects unable to understand verbal and/or written informed consent.
研究者
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