Treatment Strategies for Unruptured Intracranial Aneurysms in the Chinese Population China Treatment Trial for Unruptured Intracranial Aneurysm (ChTUIA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31,595
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
The goal of this prospective observational cohort study is to learn about treatment strategies for unruptured intracranial aneurysms in the Chinese population. The main questions it aims to answer are:
- To establish a cohort of patients with intracranial unruptured aneurysm and explore the optimal clinical treatment strategy.
- To establish clinical management path for patients with unruptured intracranial aneurysm.
According to the treatment of all patients with unruptured intracranial aneurysm, they were divided into the following groups: 1. Conservative treatment group; 2. Intracranial aneurysm clipping group; 3. Coil embolization or stent-assisted coil embolization group; 4. Flow diversion group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. age > 18 years. B. at least one intracranial aneurysm needs to be treated by craniotomy, endovascular treatment or combined surgery.
- •C. patients' consent were obtained.
排除标准
- •Ruptured intracranial aneurysms, accompanied by subarachnoid hemorrhage or cerebral hemorrhage ;
- •Traumatic, infectious and atrial myxoma-associated intracranial aneurysms ;
- •Combined with cerebrovascular malformations;
- •Combined with brain tumors or malignant tumors in other parts ;
- •Combined with systemic connective tissue disease and systemic rheumatic disease ;
- •Due to other diseases, or poor general condition, the expected survival time is not more than 12 months ;
- •During pregnancy and perinatal period.
研究组 & 干预措施
Intracranial aneurysm clipping group
Patients in Intracranial aneurysm clipping group receive neurosurgical clipping.
干预措施: observation (Other)
Coil embolization or stent-assisted coil embolization group
Patients in coil embolization or stent-assisted coil embolization group receive coil embolization or stent-assisted coil embolization according to individualized condition.
干预措施: observation (Other)
Flow diversion group.
Patients in flow diversion group receive flow diverters.
干预措施: observation (Other)
结局指标
主要结局
Primary Outcome
时间窗: 2 years
Functional outcomes(modified Rankin Scale,mRS) at 2 years after treatment decision
次要结局
- Cost(2 years)
- Aneurysm-related bleeding events(2 years)
- Mortality associated with intracranial aneurysms(2 years)
- MACCE events(1 years)
- cardiovascular/cerebrovascular events(2 years)
- All-cause mortality(2 years)
研究者
Wang Shuo
Director of Department of Cerebrovascular Neurosurgery
Beijing Tiantan Hospital