Intrasaccular neCk Occlusion deVice Treatment of Intracranial Aneurysm in Acute Subarachnoid hemorRhAGE
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- Efficacy achieving the lack of rebleeding
研究概览
简要总结
Rationale: Intrasaccular neck occlusion devices have been used for unruptured aneurysm without safety concerns and good occlusion rates. In the setting of a subarachnoid hemorrhage, they could improve the rate of complete occlusion without safety concerns.
Aim: To explore the safety and efficacy of intrasaccular neck occlusion devices in patients with acute subarachnoid hemorrhage caused by a ruptured saccular aneurysm by a one arm prospective registry.
Study outcome: The primary outcomes is the rate of complete occlusion (Raymond-Roy I) and rebleeding at one year follow-up. The primary safety outcome is rate of rebleeding during the admission.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute subarachnoid hemorrhage due to an intracranial ruptured aneurysm. Diagnosis must be done with acute CT or MRI.
- •Intracranial saccular aneurysm with neck diameter 2-11mm and neck-dome height ≥2 mm.
- •Clinical severity measured by World Federation Neurological Surgeons scale score ≤ III.
- •Age ≥18 years.
- •Previous modified Rankin scale ≤
- •Informed consent obtained from the patient or acceptable patient surrogate.
排除标准
- •Hemodynamically unstable patients with requirement of advanced vital support.
- •Patients with limited life expectancy (<6 months) due to terminal disease.
- •Previous antiplatelet or anticoagulation treatment.
- •Participation in any other clinical trial with a drug or device which could influence the outcome.
- •Patients with neurological or psychiatric disease that could undermine future evaluations.
- •Lack of availability for 12 months tracing.
结局指标
主要结局
Efficacy achieving the lack of rebleeding
时间窗: 12 months
Efficacy of the intrasaccular neck occlusion device achieving the lack of rebleeding
Efficacy achieving the complete occlusion
时间窗: 12 months
Efficacy of the intrasaccular neck occlusion device achieving the complete occlusion defined as Raymond-Roy scale score of I at 12 months follow-up evaluated by an image central core lab.
次要结局
- Rate of mortality during admission or follow-up.(12 months)
- Analysis of the primary outcomes in different subgroups(12 months)
- Efficacy achieving the complete occlusion at end of treatment(1 day)
- Rate of patients who underwent the study treatment.(1 days)
- Rate of retreatment(12 months)
- Functional outcome(12 months)
- Rate of vascular thrombosis or acute stroke.(12 months)
- Rate of early rebleeding.(30 days.)
- Rate of complications associated with the procedure.(1 day)