Xperience Pro 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
- 46
- 试验地点
- 5
- 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 Xperience Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Xperience Pro .
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 Xperience Pro 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 Xperience pro 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 and and new Target Lesion Revascularization (TLR)
次要结局
- Freedom from No reflow(During PCI)
- Efficacy Endpoint. Freedom from Target Lesion Failure(7 days)
- Freedom from Hypotube rupture(During PCI)
- Freedom from Coronary thrombosis(During PCI)
- Freedom from Coronary perforation(During PCI)
- Freedom from Coronary dissection >C(During PCI)
- Freedom from Balloon rupture(During percutaneous coronary intervention (PCI))
- Freedom from Complicated withdrawal(During PCI)