Chinese Registry of Assisted Embolization for Unruptured Wide Necked Intracranial Aneurysm Using LVIS Stent
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Major adverse events (cerebral infarct, death) in 30 days post the procedure
研究概览
简要总结
This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of unruptured intracranial saccular aneurysms.
详细描述
This study is a prospective multi-centre observational single-arm clinical trial, aiming to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents combined with coils for the treatment of unruptured intracranial saccular aneurysms. As the protocol, clinical follow-up at 30 days (±7 days) after procedure, DSA or MRA follow-up at 6 months (±30 days) after procedure, and clinical follow-up at 1 year (±30 days) after procedure was conducted for each patient. The primary end-points include major adverse events (cerebral infarct and death) in 30 days post-procedure, complete occlusion rate at 6 months (180±30d) follow-up. The secondary end-points were immediate technical success (successful device placement) rate, immediate complete occlusion rate, recurrence rate at 6 months (180±30d) follow-up and in-stent stenosis or obliteration rate at 6 months (180±30d) follow-up. Duration of this study is 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients meeting all the following criteria will be enrolled:
- •Patients of the age 18-75 years old.
- •Patients diagnosed with unruptured intracranial saccular aneurysms via CTA, MRA or DSA.
- •Patients treated with LVIS stents combined with coils.
- •Patients willing to follow the clinical trial instructions and receive follow-up assessment.
- •Patients accepting to participate to the study and sign the consent forms.
排除标准
- •Patients meeting any following criterion will be excluded:
- •Patients without proper artery approach.
- •Patients with AVM.
- •Patients with a fusiform or dissecting aneurysm.
- •Patients with a recurrent aneurysm.
- •Patients treated with a LVIS stent without coils.
- •Patients in poor clinical status, with mRS ≥
- •Patients with life expectancy less than 12 months.
- •Patients participated in other clinical trial, while has not reach the primary endpoint.
- •Patients can not accept anti-platelet regimen.
- •Patients allergic to contrast agent or intolerable.
- •Patients whom the researchers consider should not participate in or continue this clinical trial.
结局指标
主要结局
Major adverse events (cerebral infarct, death) in 30 days post the procedure
时间窗: During 30 days post the procedure
Major adverse events (cerebral infarct, death) in 30 days post the procedure is defined as post-procedural cerebral infarct or death caused by any reasons
Complete occlusion rate at 6 months (180±30d) follow-up
时间窗: At 6 months (180±30d) follow-up
Complete occlusion at 6 months follow-up is defined as 100% occlusion of aneurysmal sac proved by DSA at 6 months follow-up
次要结局
- Immediate technical success rate (successful device placement)(Within 24 hours postoperatively)
- Immediate complete occlusion rate(Within 24 hours postoperatively)
- Recurrence rate at 6 months (180±30d) follow-up(At 6 months (180±30d) follow-up)
- In-stent stenosis or obliteration rate at 6 months (180±30d) follow-up(At 6 months (180±30d) follow-up)
研究者
Qinghai Huang
Deputy Director of Neurosurgery, Clinical Professor
Changhai Hospital