FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Rate of complete aneurysm occlusion without associated stenosis of the parent artery (> 50%)
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 performed as per standard of care. The purpose of this study is to demonstrate that use of the FRED/ FRED Jr/ FRED X Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 6, 12 months and yearly up to 5 years post procedure.
150 patients will be enrolled over an 15-month recruitment period. All patients will be followed for 5 years.
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 a non-acutely ruptured intracranial aneurysm within the last 30 days of presentation:
- •for which use of FRED, FRED Jr or FRED X has been deemed appropriate
- •being the only aneurysm to require treatment within the next 12 months
- •and optionally previously treated by surgery (clipping) or with an intrasaccular device: aneurysm recanalized
- •Patient with a modified Rankin Scale (mRS) ≤ 2
- •Patient has received information about data collection and has signed and dated an Informed Consent Form
排除标准
- •Patient has suffered from an ICH within the 30 days prior to the procedure.
- •The aneurysm to be treated is associated with a cAVM
- •The aneurysm to be treated is in the posterior circulation
- •The aneurysm to be treated has a stenosis of its parent artery >50%
- •Patient has another aneurysm previously treated with a stent or a flow diverter
- •on the same parent vessel at any time
- •on a different parent vessel, less than 3 months prior to the procedure (previously-implanted stents in the non-index proximal carotid are acceptable)
- •Patient with whom anticoagulant, antiplatelet or thrombolytic drugs are contra-indicated or test performed regarding AP medication administered is not efficient for the patient
- •Patient with known hypersensitivity to contrast products or nickel titanium, not treatable
- •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/ FRED X or in addition to FRED/ FRED Jr/ FRED X is planned
结局指标
主要结局
Rate of complete aneurysm occlusion without associated stenosis of the parent artery (> 50%)
时间窗: 12 months
Complete occlusion (Raymond Scale grade I) without stenosis of the parent artery. Raymond scale definition: Grade I= complete occlusion of aneurysm, Grade II= Residual neck, Grade III= Residual aneurysm
Mortality Rate
时间窗: 6 months
Deaths within 6 months after treatment
Morbidity Rate
时间窗: 6 months
Patients with mRS\>2
次要结局
未报告次要终点