ANCRAGE: Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Acandis GmbH
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Morbi-mortality related to the device and/or procedure at 12+/-3 months post implantation
研究概览
简要总结
The aims of this clinical data collection are to investigate mortality, morbidity and neurological outcome 12 months after treatment of subject's intracranial aneurysm(s) and additionally to evaluate potential residual risks associated with the use of the commercial device(s) and to ensure the long-term safety and performance of Acandis Device(s) after its placing on the French market. On top of this, these cohorts will generate data for getting the renewal of the device's reimbursement on the French market.
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
- •The subject has an intracranial aneurysm that can be treated with one of the Acandis device indicated for the treatment of intracranial aneurysms.
- •The subject is 18 years of age or older.
- •The subject is willing to comply with scheduled visits and examinations, per institution standard of care.
排除标准
- •The subject has provided tacit opposition to data collection.
- •Any IFU warning will be considered for exclusion in the cohort.
结局指标
主要结局
Morbi-mortality related to the device and/or procedure at 12+/-3 months post implantation
时间窗: 12+/-3 months after treatment
Morbi-mortality related to the device and/or procedure at 12+/-3 months post implantation, defined as a mRS \>/= 3 for the subjects with a baseline mRS between 0 and 2 or mRS increase of 1 point for subjects with a baseline mRS greater than 2.
次要结局
未报告次要终点