A Multi-Center, Randomized, Non-Inferiority, Prospective and Parallel-Group Trial to Evaluate the Safety and Efficacy of the Interventional Robotic System for Cerebral Angiography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Clinical Success Rate
研究概览
简要总结
The goal of this multi-center clinical trial is to evaluate the efficacy and safety of the interventional robotic system for cerebral angiography, researchers will compare the ordinary angiography to assess the clinical success rate, operation time, radiation absorption, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 85 years;
- •Plan to undergo cerebral angiography;
- •Voluntarily participated in this trial and signed the informed consent form.
排除标准
- •Preoperative mRS score >2;
- •Allergy or intolerance to iodine contrast media;
- •Allergy to interventional devices;
- •Severe cardiac, hepatic and renal insufficiency;
- •Active systemic infection;
- •Severe stenosis, occlusion or skin infection at the puncture site;
- •Subjects who are to undergo surgery at the same time as cerebral angiography;
- •Subjects with severe coagulation disorders, bleeding tendencies, or contraindications to anticoagulant drugs (e.g., heparin);
- •Subjects who are enrolled in clinical studies with other devices or drugs 3 months prior to screening;
- •Female subjects of childbearing age who are pregnant or breastfeeding;
- •Other subjects who, in the judgment of the investigator, are not suitable for participation in this trial.
研究组 & 干预措施
Interventional Robotic System Assisted Surgery
Experimental group underwent cerebral angiography using the vascular interventional surgical control system
干预措施: Interventional Robotic System (Device)
Traditional Manual Surgery
The control group process the traditional manual operation for cerebral angiography
结局指标
主要结局
Clinical Success Rate
时间窗: at the end of surgery
Assessment of the clinical success rate of the surgical physician in completing cerebral angiography examination through the operation of experimental instruments or artificial means.
次要结局
- Super-selective Catheterization Time for Target Vessels(at the end of surgery)
- Super-selective Technique Success Rate(at the end of surgery)
- Instrument Performance Evaluation(at the end of surgery)
- DSA Fluoroscopy Time(at the end of surgery)
- Surgical Time(at the end of surgery)
- Primary Operator Radiation Absorbed Dose(at the end of surgery)
研究者
Jian-min Liu
Dean of the Department of Neurosurgery
Changhai Hospital