Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent - The CHOICE Study A Non-interventional, Prospective, Single-arm, International, Multicenter Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 111
- 试验地点
- 19
- 主要终点
- modified Rankin Score (mRS)
研究概览
简要总结
The objective of this study is to further establish that SQUID, an alternative liquid embolic agent with specific properties, is a safe and effective alternative in bAVM endovascular treatment strategy available to date. Therefore, the performance of SQUID will be documented and its safety of use will be confirmed in current practice.
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 planned for one or multiple embolization sessions using SQUID to achieve occlusion of a previously untreated bAVM.*
- •*Patients with a direct fistula or saccular/flow-related aneurysm previously treated with NBCA and/or coils may be included.
- •Patient in whom the use of SQUID had been decided for an embolization alone or in association to neurosurgery or radiotherapy.
- •Patient ≥18 years old.
- •Patient or authorized representative dully informed and having no objection to the clinical data collection and medical file access. An informed consent form must be signed and dated whenever required by local legislation
排除标准
- •Patient with bAVM not eligible for endovascular treatment.
- •Patient with bAVM previously treated by embolization with other devices (Liquid embolic agent, NBCA, particles, and coils).*
- •*Patients with a direct fistula or saccular / flow-related aneurysm previously treated with NBCA and/or coils may be included.
- •Patient with bAVM previously treated with surgery or radiotherapy.
- •Patient intended to undergo surgery and embolization during the same procedure at first embolization
- •Patient with multiple bAVM or bAVM associated with dural arteriovenous Fistula*.
- •*Patients with a direct fistula or saccular / flow-related aneurysm previously treated with NBCA and/or coils may be included.
- •Patient presenting contra-indication to the use of SQUID according to the Instructions For Use.
- •Intention to treat with any non-adhesive embolic liquid other than SQUID, or planned treatment with another non-adhesive embolic liquid over the course of the endovascular treatment phase.
- •Patient planned for a total endovascular treatment phase duration exceeding 2 years.
- •Patient participating in another clinical study evaluating another medical device, another procedure or a medication.
- •Any condition or any situation that would prohibit the patient from coming to the investigational center for the follow-up as recommended by the study protocol between 3 and 6 months, or prohibit carrying out the telephone mRS assessments at 1 month after each embolization session and at 12 months after the end of the endovascular treatment phase.
结局指标
主要结局
modified Rankin Score (mRS)
时间窗: 3 to 6 months after the last embolisation session
mRS is a scale used to measure the degree of handicap or dependence in daily activities of people who have suffered a stroke or other causes of neurological handicap. The scale ranges from 0 to 6, running from perfect health, without symptoms, to death. 0 - No symptoms 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Death.
次要结局
未报告次要终点