NCT02921711已完成不适用
TRAIL: Treatment of Intracranial Aneurysms With LVIS® System
Microvention-Terumo, Inc.0 个研究点目标入组 90 人开始时间: 2012年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- Retreatment rate
研究概览
简要总结
A prospective, multicenter, observational assessment of the safety and effectiveness of the LVIS® device in the treatment of wide necked intracranial aneurysms.
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
- •Patient or patient's legally authorized representative has been informed about the confidentiality of the study and has agreed to the collection of his/her personal data
- •Patient has a ruptured or unruptured intracranial aneurysm for which:
- •The parent artery has a diameter ≥ 2.0mm and ≤ 4.5 mm;
- •The aneurysm neck size is ≥ 4mm or its dome-to-neck ratio is < 2 (wide neck)
- •Endovascular treatment with coils and one or more LVIS® devices has been determined necessary for the patient by the multidisciplinary team
- •Patient is aged ≥ 18 years
- •Patient presents with a WFNS score between 0 and 3
- •Patient has agreed to attend follow-up appointments
排除标准
- •The use of an endovascular stent other than LVIS® has been determined necessary
- •Patient presents with medical or surgical co-morbidities limiting his/her life expectancy to less than one year
- •Patient has a contraindication to platelet inhibition treatment
- •Patient requires retreatment of an aneurysm previously treated with a stent
- •Patient is pregnant
- •Patient has multiple aneurysms to be treated in one procedure
结局指标
主要结局
Retreatment rate
时间窗: 18 months
Mortality rate
时间窗: 18 months
Morbidity rate
时间窗: 18 months
Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm
时间窗: 18 months
次要结局
未报告次要终点
研究者
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