An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 16
- 主要终点
- Number of Participants With Procedural Technical Success.
研究概览
简要总结
The primary objective of this study is to evaluate the effectiveness and safety of robotic-assisted endovascular embolization procedures compared to objective performance criteria for traditional, manual operation based on the scientific literature.
详细描述
This is a prospective, single-arm, international, multi- center, non-inferiority study to evaluate the effectiveness and safety of the CorPath GRX System for endovascular cerebral aneurysm embolization compared to historical controls. Subject selection requires a clinical indication for endovascular coil and/or stent-assist coiling embolization of cerebral aneurysms.
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
- 是
入选标准
- •Age ≥ 18 years.
- •At least one cerebral aneurysm (unruptured) with indication for endovascular treatment; dome to neck ratio >1.5 or aneurysm neck width >4.0 mm.
- •The Investigator deems the procedure appropriate for both manual or robotic-assisted endovascular treatment.
- •The conscious 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 / unwillingness of the subject to provide informed consent, unless the EC has waived informed consent.
- •The Investigator determines that the subject or the neurovascular anatomy is not suitable for robotic-assisted endovascular treatment.
- •Women who are pregnant.
- •Persons under guardianship or curatorship.
结局指标
主要结局
Number of Participants With Procedural Technical Success.
时间窗: Measured from the start of the procedure to the end of the procedure.
The primary effectiveness endpoint will be defined as successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual for guidewire or microcatheter navigation, embolization coil(s) or intracranial stent(s) deployment, or an inability to navigate vessel anatomy.
Number of Intra- and Peri-procedural Events.
时间窗: Measured from the start of the procedure through 24 hours or discharge, whichever occurs first.
The primary safety endpoint will be a composite of intra- and periprocedural events, including target aneurysmal rupture, vessel perforation or dissection, and thromboembolic event with neurological decline within 24-hours post- procedure or hospital discharge, whichever occurs first.
次要结局
- Robotically Navigate Device to the Target Aneurysm(Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.)
- Robotically Deploy Therapeutic Device Into the Target Aneurysm(Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.)
- Overall Procedure Time(Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.)
- Fluoroscopy Time(Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.)
- Patient Radiation Exposure(Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.)
- Contrast Fluid Volume(Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure.)
- Adverse Events(Measured from the start of the procedure through end of the study. Measured from the start of the procedure to the end of the procedure. Measured from the start of the procedure to the end of the procedure. Subjects will undergo clinical follow-up th)
- Number of Thromboembolic Events(Measured from the start of the procedure through end of the study (180-days following the robotic-assisted procedure).)
- Devices Used Robotically(Measured from the start through end of the procedure. Subjects will also undergo clinical follow-up through 180 day)
- Number of Participants With Aneurysm Occlusion(Assessed During Procedure (Post Intervention))