NCT06631157招募中不适用
Essential Pro Post-Market Clinical Follow-up Study
Fundación EPIC1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety Endpoint. Freedom from Target Lesion Failure
研究概览
简要总结
Single center, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Essential Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Essential Pro.
详细描述
This study intends to analyze:
- Device effectiveness (in its individual use, technical performance) and procedural effectiveness (technical outcome at the end of lesion treatment with the device under study and any other device being used).
- Device safety (in its individual use, technical performance) and procedural safety (technical outcome at the end of lesion treatment with the device under study and any other device being used).
- Clinical outcomes at the end of the procedure and during the specified follow-up period for each device. The follow-up timeframe is established based on the conditions of use and type of device being used, according to the requirements established by the relevant Notified Body.
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 Essential Pro according to routine hospital practice and following instructions for use
- •Informed consent signed
排除标准
- •Not meet inclusion criteria
研究组 & 干预措施
Coronary Artery Disease (CAD)
干预措施: Essential pro (Device)
结局指标
主要结局
Safety Endpoint. Freedom from Target Lesion Failure
时间窗: 12 months
Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR). 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)(12 months)
- Freedom from Balloon rupture(During PCI)
- Freedom from Hypotube rupture(During PCI)
- Freedom from Complicated withdrawal(During PCI)
- Freedom from Coronary perforation(During PCI)
- Freedom from Coronary dissection >C(During PCI)
- Freedom from No reflow(During PCI)
- Freedom from Coronary thrombosis(During PCI)
研究者
研究点 (1)
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