Safety and Feasibility of On-Premise and Remote Robotic Neurointervention
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- Procedural Technical Success
研究概览
简要总结
This study is a prospective, single arm, single-center study to evaluate the safety and feasibility of the Remedy Robot for on premise and remote robotic Neurointervention.
详细描述
This is a prospective, single-arm, single-center study to evaluate the safety and effectiveness of the Remedy Robot for patients with a clinical indication for Neurointervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 是
入选标准
- •The patient is ≥ 18 years of age
- •The Investigator deems the patient appropriate for manual and robotic-assisted Neurointervention.
- •The patient or their substitute decision-maker has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
排除标准
- •Patients currently pregnant or breastfeeding.
- •People with any of the following vascular history:
- •Known congenital aortopathy, connective tissue disorder or vasculopathy
- •Known arterial dissection of any kind
- •Bleeding diathesis
- •Use of Warfarin, IV Heparin, Clexane, Fondaparinux or any new oral anticoagulants (NOACs) or direct oral anticoagulants (DOACs)
- •People with any of the following medical history:
- •Active malignancy
- •Known contrast allergy
- •Height > 190cm
结局指标
主要结局
Procedural Technical Success
时间窗: Measured from the start of the procedure through to the completion of the procedure
Successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual control
Procedural safety
时间窗: Measured from the start of the procedure through 24 hours or discharge
Incidence of intra- and peri-procedural events, including all cause mortality, stroke, arterial dissection, arterial perforation
次要结局
未报告次要终点