Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Incidence of complications / adverse events (Safety)
研究概览
简要总结
A non-interventional multicentric study for patients with a cerebral AVM for which endovascular treatment is indicated.
详细描述
This observational study will collect data about the treatment of ruptured, unruptured, untreated or endovascular previously treated AVM's.
Primary endpoint is safety. Safety will be assessed with the number of procedure-related complications occurring during the endovascular treatment until 30 days after the final embolization.
Secondary endpoint is efficacy. Efficacy will be assessed by angiography and clinical outcome assessments (mRS).
For each patient enrolled, data will be collected at inclusion, at each embolization session and at 6 ± 1 months after the end of the endovascular treatment phase.
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 must sign the informed consent form prior to the index-procedure. If patient is unable to provide it him- or herself because of the patient's medical condition, the informed consent of the patient's legally authorized representative shall be requested.
- •The patient has an untreated or endovascular previously treated cerebral AVM for which endovascular treatment is indicated.
- •The patient is at least 18 years old.
排除标准
- •Patient is pregnant.
- •Patient with renal insufficiency (GFR < 45 ml/min/1.73 m²)
结局指标
主要结局
Incidence of complications / adverse events (Safety)
时间窗: From the start of the procedure until 30 days after procedure
The safety is assessed with the number of procedure-related complications occurring during endovascular treatment until 30 days after the final embolization session. Procedure-related complications include complications/adverse events related to the procedure or to the device such as but not limited to hemorrhagic and ischemic complications.
次要结局
- Clinical outcome measurement with mRS (Efficacy)(At 6 months after the last treatment session, compared to baseline)
- Degree of targeted portion of AVM occlusion(6 months)