A Post-Market Study in Japan 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
- 242
- 试验地点
- 8
- 主要终点
- Technical 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 in the first 231 patients treated with the CorPath device in Japan.
详细描述
This is a single-arm, open-label, multi-center patient registry in Japan 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 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, unless the EC has waived informed consent.
排除标准
- •Failure/inability/unwillingness to provide informed consent, unless the EC has waived 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
Technical Success
时间窗: During 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.
Residual stenosis in the lesion(s) treated
时间窗: Through end of subject's participation in the study, an average of up to 3 days.
Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse cardiac events (MACE) as assessed by the Angiographic Core Laboratory (ACL).
次要结局
- Major adverse cardiac events (MACE)(Through end of subject's participation in the study, an average of up to 3 days.)
- Overall Procedure Time(During procedure)
- Patient Radiation Exposure(During procedure)
- Operator Radiation Exposure(During procedure)
- PCI Procedure Time(During procedure)
- IVUS/OCT/IVUS-OCT Time (if used)(During procedure)
- Fluoroscopy Time(During procedure)