A Multicenter Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 952
- 试验地点
- 20
- 主要终点
- Clinical Success
研究概览
简要总结
To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath GRX System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.
详细描述
This is a single-arm, open-label, multi-center patient registry of the CorPath GRX System to examine its performance during PCI procedures and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.
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
- •Candidates will be included in the study only if all of the following conditions are met:
- •Age ≥18 years;
- •Patients with coronary artery disease with clinical indication for PCI;
- •Patient deemed appropriate for robotic-assisted PCI; and
- •The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
排除标准
- •Candidates will be excluded from the study if any of the following conditions are present:
- •Failure/inability/unwillingness to provide informed consent; or
- •The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.
结局指标
主要结局
Clinical Success
时间窗: Discharge or 72 hours post intervention, whichever comes first.
Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse coronary events (MACE).
Technical Success
时间窗: Procedure
Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.
次要结局
- Overall Procedure Time(Procedure)
- Fluoroscopy Time(Procedure)
- Patient Radiation Exposure(Procedure)
- PCI Procedure Time(Procedure)