CEFloW (Clinical Experience With Flow Diverter With and Without Movable Wire)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Phenox GmbH
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Morbi-Mortality Rate
研究概览
简要总结
To evaluate safety and performance of the phenox GmbH Flow Diverter p64, p64 MW, and p48MW in France, this registry will include subjects with intracranial aneurysms (anterior and posterior) who are treated with a phenox GmbH Flow Diverter. The subjects will be treated according to the standard of care in the participating sites.
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
- •1. Age ≥ 18 years and legally of age.
- •2. The patient has intracranial aneurysm(s) * and is treated or planned to be treated with p64, p48 MW or p64 MW Devices. (*cases of ruptured aneurysms in the context of a staged procedure or not treatable by another technique, and cases of multiple aneurysms are eligible)
- •3. The patient or his/her legal representative (in case the patient does not have the capacity due to his/her clinical condition), does not object to the collection and processing of the data specified in the protocol.
排除标准
- •1. Participation in an interventional study modifying standard patient care management (e.g. COATING study)
- •2. State or circumstance that does not allow the patient to undergo the standard site's follow-up for aneurysm treatment
研究组 & 干预措施
Subjects with intracranial aneurysms (anterior and posterior) treated with p64, p48 MW and p64 MW
The registry will include subjects across France who are treated for an intracranial aneurysm with a p64, p64 MW or p48 MW Flow Modulation Device.
In total, it is anticipated to include approximatively 200 subjects over the inclusion period: 160 subjects treated with p64 /p64 MW (80 %) and 40 subjects treated with p48 MW (20 %).
干预措施: Aneurysm treatment with a Flow Modulation Device (Device)
结局指标
主要结局
Morbi-Mortality Rate
时间窗: 12 Months
The morbi-mortality rate related to procedure/device at 12 months post-procedure defined by an mRS ≥ 3 in subjects with an mRS less than or equal to 2 prior to the procedure or a 1-point increase over the initial mRS score in subjects with an mRS above 2 prior to the procedure (in the case of ruptured aneurysms, a pre-rupture reconstituted mRS will be collected ).
次要结局
- Percentage of Device deficiencies(12 Months)
- Percentage of patients with intra-procedural complications(During Procedure)
- Percentage of patients with post-procedural complications up to discharge(After Procedure up to Discharge (estimated at 72hrs after procedure))
- Percentage of patients with post-discharge complications(12 Months)
- Percentage of patients with a complete occlusion of the target aneurysm(12 Months)
- Percentage of patients with a retreatment of the target aneurysm(12 Months)