Mid-term Data Collection of the Treatment of Intracranial Aneurysms With the WEB™ Aneurysm Embolization System: a Monocentric Post-market Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA
研究概览
简要总结
Flow disruption is a new endovascular approach for treatment of both ruptured and unruptured intracranial aneurysms, which involves placement of an endosaccular device (WEB) which modifies the blood flow at the level of the neck and induces intraaneurysmal thrombosis. The WEB was designed to treat wide-neck bifurcation aneurysms. This observational study will collect data about the routine practice in one center of using the WEB in ruptured and unruptured intracranial aneurysms. The primary objective is to evaluate its efficacy by assessing the anatomic outcome during follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between 18 and 80 years old.
- •Patient must sign and date the informed consent form <72hrs post-procedure and prior to data registration. If patient is not able to give informed consent for himself/herself, a legally authorized representative must give informed consent on his/her behalf.
- •Patient has a ruptured (Hunt and Hess grades 1, 2 or 3) or unruptured intracranial aneurysm requiring endovascular treatment.
- •Aneurysm with dome-to-neck ratio ≥ 1.
排除标准
- •Aneurysm size unfavourable for WEB implantation (aneurysm width > 10 mm or aneurysm width < 3mm).
- •Patient with Hunt and Hess grades 4 or
- •Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).
- •Parent vessel occlusion.
结局指标
主要结局
Determination of anatomic outcome: grade of occlusion of the aneurysm assessed by MRA
时间窗: at 24 months follow-up
WEB Occlusion Scale: WOS A: complete occlusion WOS B: complete occlusion with opacification of the proximal recess WOS C: residual neck filling WOS D: residual aneurysm filling
次要结局
- Recording the use of additional devices during treatment to occlude the aneurysm(During index-procedure)
- Recording of intracranial haemorrhage during follow-up(up to 24 months)
- Determination of 30 day mortality(up to 30 days)
- Determination of procedural complications (Adverse events) during the operation(During index-procedure)
- Determination of the technical success of the device defined as device deployment in the target aneurysm as intended by the investigator with complete apposition against the aneurysm wall.(During index-procedure)
- Need for repeat treatment during follow-up(up to 24 months)
- Determination of the occurrence of post-procedural symptomatic thromboembolic events(up to 24 months follow-up)
- Determination of clinical outcome: assessing disability of the patient by the modified Rankin Scale (mRS)(at 24 months follow-up)
- Determination of overall mortality(up to 24 months)