Cardiac Cath Lab Staff Radiation Exposure During Chronic Total Occlusion PCI: CorPath GRX vs. Manual
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Clinical Success
研究概览
简要总结
The objective of this randomized safety and observational study is to demonstrate CorPath GRX chronic total occlusion PCI is safe, and that Cardiac Catheterization Laboratory staff have no additional exposure to radiation when compared to conventional manual chronic total occlusion PCI procedures without added procedure time.
详细描述
This is prospective, dual-arm, randomized, multi-center, observational study comparing patient outcomes and staff radiation exposure in chronic total occlusion PCI procedures through 48 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
- •CTO lesion, successfully crossed with conventional manual techniques;
- •The Investigator deems the procedure appropriate for robotic-assisted CTO PCI with the CorPath GRX System;
- •Individual monitoring of radiation dose, using the pocket dosimeter, was initiated at start of procedure;
- •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
- •Failure/inability/unwillingness to provide informed consent, or
- •Cardiogenic Shock; or
- •Perforation which requires treatment (e.g. covered stent, coil and other embolization techniques, or pericardiocentesis).
结局指标
主要结局
Clinical Success
时间窗: 48 hours
Defined as successful CTO PCI revascularization with achievement of \<30% residual diameter stenosis (visual estimate) within the treated segment and restoration of antegrade TIMI grade 3 flow, without in-hospital major adverse events (MAE).
In-hospital Major Adverse Events (MAE)
时间窗: 48 hours
Number of MAE events that occurs within 48 hours of the CTO PCI procedure or hospital discharge, whichever occurs first.
次要结局
- Operator Radiation Exposure(Procedure)
- Staff Radiation Exposure(Procedure)
- Patient Radiation Exposure(Procedure)
- Fluoroscopy Time(Procedure)