CorPath® 200 RAPID II Study (Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical Success
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of the CorPath 200 System in the remote delivery and manipulation of guidewires and rapid exchange catheters for use in percutaneous vascular interventions.
详细描述
This is a prospective, single-arm, single center, non-randomized feasibility study of the CorPath 200 System to examine its performance during complete interventions (DCB, Stenting) of the femoropopliteal arteries and patient outcomes at 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •General Inclusion Criteria
- •At least 18 years of age;
- •Symptomatic disease: presence of critical limb ischemia (including tissue loss or rest pain), or lifestyle-limiting claudication requiring intervention in the femoropopliteal arteries; and
- •The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.
- •Angiographic Inclusion Criteria Femoropopliteal artery lesion(s) with stenosis (>50%) or occlusion of up to 120 mm in length as determined by imaging (MRA or Angio) prior to index interventional procedure.
排除标准
- •General Exclusion Criteria
- •If any of the following criteria are met, the subject cannot be enrolled in this study:
- •Failure/inability/unwillingness to provide informed consent;
- •Target vessel has been previously treated with bypass; or
- •Enrolled in concurrent clinical study.
- •Angiographic Exclusion Criteria
- •Target vessel:
- •Shows evidence of previous dissection or perforation, or
- •Has adjacent acute thrombus; or
- •Has a pre-existing target artery aneurysm or perforation or dissection of the target artery prior to initiation of the interventional procedure.
研究组 & 干预措施
Robotic-assisted PVI
Robotic-assisted peripheral vascular intervention
干预措施: Robotic-assisted peripheral vascular intervention (Device)
结局指标
主要结局
Clinical Success
时间窗: 72 hours or hospital discharge, whichever comes first.
Defined as \<50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure in the absence of device-related serious adverse events (SAE).
Adverse Events
时间窗: Procedure
No device-related serious adverse events.
次要结局
- Patient Radiation Exposure Dose(Procedure)
- Operator Radiation Exposure Dose(Procedure)