Post-Market Application Study and Efficacy/Safety Evaluation of a Vascular Interventional Robotic System for Cerebral Angiography: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 660
- 试验地点
- 2
- 主要终点
- Angiography Success Rate
研究概览
简要总结
This study aims to conduct a post-market, multicenter clinical trial utilizing an interventional robotic system for cerebral angiography. By comparing it with traditional angiography procedures, the study will systematically evaluate the efficacy and safety of robot-assisted angiography in real clinical settings. Researchers will compare the ordinary angiography to assess the clinical success rate, operation time, radiation absorption, complication rate, 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years;
- •Suspected vascular lesions in the head and neck, or other conditions involving head and neck vessels requiring whole-brain angiography for definitive diagnosis or to aid treatment decisions. Including but not limited to: intracranial aneurysms, arteriovenous malformations, cavernous malformations, arteriovenous fistulas, Moyamoya disease, Moyamoya syndrome, subarachnoid hemorrhage, symptomatic intracranial artery stenosis/occlusion, stenosis/occlusion of the carotid/subclavian/vertebral arteries, acute/ chronic subdural hematoma, etc;
- •American Society of Anesthesiologists (ASA) physical status classification I-III (no severe cardiopulmonary dysfunction);
- •Patients who voluntarily participate in this study and sign an informed consent form.
排除标准
- •Patients who are to undergo surgery at the same time as cerebral angiography;
- •Renal dysfunction (serum creatinine > 133 μmol/L or estimated glomerular filtration rate < 60 mL/min/1.73 m²);
- •Patients with known allergy to iodinated contrast media;
- •Coagulation disorders (prothrombin time >16s, activated partial thromboplastin time >45s, or platelet count <100×10⁹/L);
- •Severe infection, skin ulceration, or vascular anatomical abnormalities at the puncture site (e.g., bilateral femoral artery occlusion);
- •Pregnant or lactating women;
- •Patients with severe cognitive impairment;
- •Patients with psychiatric disorders;
- •Patients unable to undergo head magnetic resonance imaging (MRI), e.g., those with metallic implants, claustrophobia, or other contraindications;
- •Patients with other severe advanced or terminal illnesses;
- •Patients currently participating in other clinical trials.
研究组 & 干预措施
Vascular Interventional Robotic System Assisted Angiography
干预措施: Vascular Interventional Robotic System (Device)
Traditional Manual Endovascular Angiography
结局指标
主要结局
Angiography Success Rate
时间窗: At the end of surgery
Assessment of the success rate of the surgeon in completing cerebral angiography examination through the operation of vascular interventional robotic system or manual way.
Complication Rate
时间窗: At the day after surgery
Potential complications include: ① Directly related to the interventional procedure: Vascular injury (vessel rupture, perforation, spasm, gas embolism, and thrombosis); ② Neurological complications: New-onset neurological deficits (transient/permanent), new-onset cerebral ischemia, or new-onset intracerebral hemorrhage, confirmed by postoperative imaging; ③ Systemic complications: Cardiac events, gastrointestinal bleeding, renal dysfunction, etc.
次要结局
- Operation Time(At the end of surgery)
- Super-selective Success Rate(At the end of surgery)
- Super-selective Catheterization Time for Vessels(At the end of surgery)
- Primary Operator Radiation Absorbed Dose(At the end of surgery)
- Participant Radiation Absorbed Dose(At the end of surgery)
- Vascular Interventional Robotic System Performance Evaluation(At the end of surgery)
- Frequence of robotic operations transition to manual operations(At the end of surgery)
- Operation Preparation Time(At the end of Surgery)
- Operation Time(At the end of surgery)
- Super-selective Success Rate(At the end of surgery)
- Super-selective Catheterization Time for Vessels(At the end of surgery)
- Digital Subtraction Angiography (DSA) Fluoroscopy Time(At the end of surgery)
- Primary Operator Radiation Absorbed Dose(At the end of surgery)
- Participant Radiation Absorbed Dose(At the end of surgery)
- Vascular Interventional Robotic System Performance Evaluation(At the end of surgery)
- Frequence of robotic operations transition to manual operations(At the end of surgery)
- Operation Preparation Time(At the end of Surgery)
研究者
Yuanli Zhao
Director of the Department of Neurosurgery
Peking Union Medical College Hospital