NCT04459299终止不适用
An Evaluation of Performance of the CorPath® GRX System in Robotic-PCI During Acute STEMI
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Time from Catheterization Lab Arrival to Device Activation (CLADA) by CorPath GRX System.
研究概览
简要总结
This study will evaluate the performance of the CorPath GRX System in Robotic Primary PCI (RPPCI) in the treatment of ST-elevated myocardial infarction (STEMI).
详细描述
This is a prospective, post-market, single-arm, multi-center, observational study to evaluate the performance of the CorPath GRX System during robotic-PCI for acute ST elevation myocardial infarction (STEMI).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤ 80 years
- •Patients with STEMI<12 h of symptom onset
- •Patient deemed appropriate for robotic-assisted PCI
- •The subject has been informed of the nature of the study, agrees to its provisions, and has provided written consent
排除标准
- •Cardiogenic shock
- •Cardiac arrest
- •Need for manual or mechanical thrombectomy
- •Failure/inability/unwillingness to provide informed consent
- •The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted primary PCI treatment
结局指标
主要结局
Time from Catheterization Lab Arrival to Device Activation (CLADA) by CorPath GRX System.
时间窗: Procedure
Time measured from arrival to Cath Lab to device activation by CorPath GRX System.
次要结局
- Freedom from MACE events(72-hours)
- Access to device activation(Procedure)
- Overall procedure time(Procedure)
- Conversion to manual (Binary)(Procedure)
- Access to wire time(Procedure)
- Contrast fluid volume(Procedure)
- Serious adverse events(72-hours)
- First Medical Contact (FMC) to device activation time(Procedure)
- Fluoroscopy time(Procedure)
- Patient radiation exposure(Procedure)
- Technical success(Procedure)
研究者
研究点 (1)
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