A Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Peripheral Vascular Interventions
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Technical Success
研究概览
简要总结
This study will evaluate real-world performance of the CorPath GRX System in peripheral vascular interventions.
详细描述
This is a prospective, single-arm, open-label, multi-center registry of the CorPath GRX System to evaluate its real-world performance during peripheral vascular interventions.
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
- •Age ≥ 18 years.
- •Subject has a clinical indication for Peripheral Vascular Intervention (PVI).
- •Subject is deemed appropriate for robotic-assisted PVI.
- •The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- •Individual monitoring of radiation dose, using the pocket dosimeter, was initiated at start of procedure.
排除标准
- •Failure/inability/unwillingness to provide informed consent.
- •The investigator determines the subject or the peripheral anatomy is not suitable for ro-botic-assisted PVI.
- •Women who are pregnant.
结局指标
主要结局
Technical Success
时间窗: Procedure
Successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy.
Clinical Success
时间窗: Within 24 hours of the procedure or hospital discharge, whichever occurs first.
\<30% residual stenosis in all CorPath System treated lesions at the completion of the interventional procedure in the absence of device-related serious adverse event (SAE).
Safety
时间窗: Within 24 hours of the procedure or hospital discharge, whichever occurs first.
A composite of intra- and peri-procedural events, including target vessel rupture, clinically significant perforation or dissection, and distal embolization.
次要结局
- PVI Procedure Time(Procedure)
- Operator Radiation Exposure(Procedure)
- Staff Radiation Exposure(Procedure)
- Robotic Time(Procedure)
- Manual Time(Procedure)
- Fluoroscopy Time(Procedure)
- Patient Radiation Exposure(Procedure)
- Contrast Fluid Volume(Procedure)