Results of Revascularization Versus Endovascular Flow Diversion in Treatment of Complex Intracranial Aneurysms of Anterior Circulation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- mRS
研究概览
简要总结
The investigator expects that endovascular flow-diversion is superior over revascularization by postoperative modified Rankin scale (mRS) in patients with complex intracranial aneurysms.
详细描述
Open, prospective, controlled randomized superiority trial is conducted. The hypothesis is that endovascular flow-diversion is better than revascularization in treatment of complex intracranial aneurysms by postoperative modified Rankin Scale (mRS). Sample size was measured by Fisher exact test. Depending on a type of the procedure, the patients are divided into two groups: Endovascular Flow Diversion Procedure (include 55 patients) and Revascularization Procedure (include 55 patients). Randomization is performed by random number generation.The study was approved by Institutional Review Board
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •anterior circulation complex intracranial aneurysm
- •neck is more than 4 mm wide
- •dome/neck ratio of aneurysm equals or less than 2:1
- •age less than 75 years
- •ability to give informed consent (subject or legally authorized representative)
- •aneurysm is suitable for treatment to both procedures
排除标准
- •subarachnoid hemorrhage less than 30 days ago
- •contraindications to endovascular treatment
- •atypical aneurysms (mycotic, flow-related in patients with AVM, traumatic, false)
- •informed consent refusal
研究组 & 干预措施
Endovascular Flow-Diversion
Implantation of flow-diversion device
干预措施: Endovascular Flow-Diversion (Procedure)
Cerebral Revascularization
Cerebral revascularization procedure with trapping of aneurysm
干预措施: Cerebral Revascularization (Procedure)
结局指标
主要结局
mRS
时间窗: 6, 12 months after procedure
Change from baseline modified Rankin Scale
次要结局
- Complete aneurysm occlusion(6, 12 months after procedure)
- Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm(6, 12 months after procedure)