NAVISCORE Post-Market Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 7
- 主要终点
- Safety Endpoint. Freedom from Target Lesion Failure
研究概览
简要总结
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Naviscore scoring balloon to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Naviscore.
详细描述
The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Naviscore scoring balloon in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.
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
- •Patient treated with Naviscore according to routine hospital practice and following instructions for use
- •Informed consent signed
排除标准
- •Not meet inclusion criteria
结局指标
主要结局
Safety Endpoint. Freedom from Target Lesion Failure
时间窗: 7 days
Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR).
次要结局
- Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)(7 days)
- Freedom from Coronary perforation(During PCI (Percutaneous Coronary Intervention))
- Freedom from Hypotube rupture(During PCI (Percutaneous Coronary Intervention))
- Freedom from Complicated withdrawal(During PCI (Percutaneous Coronary Intervention))
- Freedom from Balloon rupture(During PCI (Percutaneous Coronary Intervention))
- Freedom from Coronary dissection >C(During PCI (Percutaneous Coronary Intervention))
- Freedom from Coronary thrombosis(During PCI (Percutaneous Coronary Intervention))
- Freedom from No reflow(During PCI (Percutaneous Coronary Intervention))