NCT02921698已完成不适用
Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
Microvention-Terumo, Inc.0 个研究点目标入组 100 人开始时间: 2014年7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
- 100
- 主要终点
- Aneurysm occlusion without ˃ 50% parent artery stenosis
研究概览
简要总结
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of 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 is aged ≥18 years
- •Patient has an unruptured or recanalized intracranial aneurysm :
- •for which an endovascular treatment has been determined appropriate
- •that can not be treated by standard techniques (coiling with or without remodeling)
- •and for which the FRED® Flow Diverter has been determined an appropriate treatment
- •Patient or patient's legally authorized representative has been informed about the confidentiality of the study and agrees to the collection of his/her personal data
- •Patient presents with an mRS score between 0 and 2
- •Patients who have already been treated with a stent or a flow diverter for another aneurysm may be included if:
- •the previous treatment was more than three months prior to enrollment in this study
- •the aneurysm to be treated for this study is a new aneurysm located on a different parent vessel unless the stent already in place is implanted on the proximal carotid artery.
排除标准
- •Patient has a known allergy to antiplatelet therapy, heparin and/or contrast medium
- •Patient has contraindication to antiplatelet therapy and/or heparin
- •Patient is pregnant and/or breastfeeding
- •Patient may not benefit from imaging and clinical monitoring
- •Patient has a medical or surgical co-morbidities limiting his/her life expectancy to less than 1 year
- •Patient will be treated with a flow diverter other than FRED®
- •Patient had an intracranial hemorrhage within the 30 days preceding treatment
- •Patient has an aneurysm(s) with one or more of the following characteristics:
- •associated with an arteriovenous malformation
- •dissecting or ""blister-like""
- •multiple (unless only one aneurysm requires treatment)
- •located in the posterior circulation
- •treated with a stent or a flow diverter on the same parent vessel (excluding proximal carotid artery) or in the 3 months prior to inclusion
- •Patient has stenosis of the aneurysm parent artery.
结局指标
主要结局
Aneurysm occlusion without ˃ 50% parent artery stenosis
时间窗: 6 months
Morbidity rate
时间窗: 6 months
Mortality rate
时间窗: 6 months
次要结局
未报告次要终点
研究者
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