Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment, a UK, Multi-center, Single Arm, Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 7
- 主要终点
- Morbidity rate
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
详细描述
This is a multi-center observational study. Treatment and follow-up visits will be done as per standard of care.
The purpose of this study is to demonstrate that use of the FRED/FRED Jr Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 1, 6 and 12 month post procedure.
100 patients will be enrolled over an 18-month recruitment period. All patients will be followed for 12 months.
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 older than 18 years old
- •Patient harboring an unruptured intracranial aneurysm:
- •for which endovascular treatment is indicated
- •for which use of FRED or FRED Jr has been deemed appropriate
- •being the only one to require treatment over the period of the study
- •and optionally previously treated by surgery (clipping) or with an intrasaccular device: aneurysm recanalized
- •Patient with a modified Rankin Scale (mRS) ≤ 2
- •Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
排除标准
- •Patient has suffered an ICH within the 30 days prior to the procedure.
- •The aneurysm to be treated is associated with an cAVM
- •The aneurysm to be treated is a dissecting or blister-like aneurysm
- •The aneurysm to be treated or any other aneurysm is in the posterior circulation
- •The aneurysm to be treated has a stenosis of its parent artery
- •Patient has another aneurysm previously treated with a stent or a flow diverter
- •on the same parent vessel at any time (except in the case of the proximal carotid if the treatment occurred more than 3 months prior to the procedure)
- •on a different parent vessel, less than 3 months prior to the procedure
- •Patient has another aneurysm requiring treatment within the study period
- •Patient with a known allergy to antiplatelet, to heparin, to contrast products or nickel titanium
- •Patient with a contra-indication to antiplatelet or heparin
- •Pregnancy or child breastfeeding
- •Patient unable or unlikely to complete required follow up
- •Patient has severe or fatal comorbidity or a life expectancy of less than 1 year
- •Treatment with a flow diverter other than FRED/FRED Jr or in addition to FRED/FRED Jr is planned.
结局指标
主要结局
Morbidity rate
时间窗: 6 months
patients with mRS\>2
Mortality rate
时间窗: 6 months
patients with mRS=6
Complete aneurysm occlusion without ˃ 50% parent artery stenosis
时间窗: 6 months
Evaluated by Corelab
次要结局
未报告次要终点