Robot-assisted Neurovascular Intervention for Patients Indicated for Angiography, Cerebral Artery Embolization, and Thrombectomy: Exploratory Study to Compare to Existing Interventional Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Success rate of target vessel access
研究概览
简要总结
Patients scheduled for neurovascular interventions may be eligible to have their procedure done robotically.
详细描述
Patients scheduled for manual neurovascular interventions, such as diagnostic cerebral angiography for cerebrovascular diseases, arterial embolization for meningioma treatment, and thrombectomy for thrombotic arterial occlusion-induced cerebral ischemia, may be considered to participate in this study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for neurovascular interventions, such as diagnostic cerebral angiography for cerebrovascular diseases, arterial embolization for meningioma treatment, and thrombectomy for thrombotic arterial occlusion-induced cerebral ischemia, are selected according to the same criteria as standard cerebral angiography and interventional procedures.
排除标准
- •Exclusion Criteria 1 (General):
- •Patients who have undergone surgery within 4 weeks prior to study participation or have not fully recovered from surgery.
- •Patients who are pregnant or breastfeeding.
- •Patients with existing or anticipated vasospasm, bleeding, or severe atheromatous disease.
- •Patients allergic to contrast agents used in angiography.
- •Patients with renal failure.
- •Patients with a history of cardiac events, such as myocardial infarction or superior vena cava (SVC) syndrome, within 3 months prior to study participation, or with existing heart disease.
- •Patients unable to cooperate due to difficulty in expressing intent to the extent that the procedure cannot proceed.
- •Patients with severe or life-threatening comorbidities that could significantly affect symptom improvement or render the procedure unbeneficial.
- •Patients with non-life-threatening comorbidities that prevent proper follow-up for treatment.
- •Exclusion Criteria 2 (Cerebral Ischemic Stroke Patient):
- •Patients with an ASPECTS score of 0-2 on a pre-treatment non-contrast CT.
- •Inability to perform femoral puncture within 60 minutes of completing CT angiography (if CT perfusion is performed, it must be done after CT angiography).
- •Absence of a femoral pulse.
- •Cases where vascular access is highly challenging, with an anticipated time exceeding 90 minutes from CT angiography to reperfusion.
- •Patients suspected to have cerebral artery dissection or atherosclerosis as the cause of stroke.
- •Patients where the intracranial occlusion is determined to be chronic based on clinical history, prior imaging, or clinical judgment.
研究组 & 干预措施
Robot Assisted Neurovascular Intervention
Patients will undergo robot-assisted neurovascular interventions.
干预措施: cerebral angiography, arterial embolization, thrombectomy (Procedure)
Robot Assisted Neurovascular Intervention
Patients will undergo robot-assisted neurovascular interventions.
干预措施: Cerebral angiogram using robotic device (Device)
Robot Assisted Neurovascular Intervention
Patients will undergo robot-assisted neurovascular interventions.
干预措施: Meningioma embolization using robotic device. (Device)
Robot Assisted Neurovascular Intervention
Patients will undergo robot-assisted neurovascular interventions.
干预措施: Mechanical thrombectomy for stroke using a robotic device. (Device)
结局指标
主要结局
Success rate of target vessel access
时间窗: From enrollment through end of procedure.
Measurement Parameters: The primary outcome assesses whether the Vasco Robotic system navigates catheter or other procedural devices successfully to the target vessel.
次要结局
未报告次要终点