Microvention Aneurysm & Stroke Real-life Data Collection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Cohort 2: Proportion of patients achieving final mTICI ≥ 2b revascularization
研究概览
简要总结
The MAESTRO registry is a post-market, single-arm, non-interventional, multicenter registry
详细描述
Electronic platform to collect real-world clinical data, evaluate and periodically report safety and effectiveness of CE approved and commercially available Microvention devices used for the endovascular treatment of Intracranial aneurysms and acute ischemic stroke.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, or another authorized person as per country-specific regulations, is informed of the data collection and gives non-opposition or consent prior to the data collection in accordance with institutional and geographic requirements.
- •For Cohort 1, patient is treated for a ruptured or unruptured intracranial aneurysm using a commercially available MicroVention implant device as the primary treatment device and the decision to use this device has been made by the treating physician outside the context of the MAESTRO study.
- •For Cohort 2, patient is treated using a commercially available MicroVention mechanical thrombectomy device as the first-line treatment strategy and the decision to use this device has been made by the treating physician outside the context of the MAESTRO study.
- •Note: For the purposes of this protocol, ancillary/accessory devices such as balloon catheters, carotid stent for extracranial stenosis and other access devices are not considered primary treatment devices. Further, devices used for rescue following attempt of a different primary treatment device are not considered initial primary treatment devices.
排除标准
- •Patient is or is expected to be inaccessible for follow-up.
- •Patient is participating or intends to participate in another study that changes the site practice.
- •Patient is already participating in the MAESTRO study for the same pathology.
研究组 & 干预措施
1
Cohort 1 will focus on data collection on all Microvention Class III implantable device CE marked used in the treatment of intracranial aneurysms
干预措施: All Microvention Class III implantable device CE marked (Device)
2
Cohort 2 will focus on data collection on all Microvention Class III device CE marked used in the treatment of Acute Ischemic Stroke
干预措施: All Microvention Mechanical Thrombectomy Class III device CE marked (Device)
结局指标
主要结局
Cohort 2: Proportion of patients achieving final mTICI ≥ 2b revascularization
时间窗: Mechanical trombectomy Procedure
based on independent Corelab assessment
Cohort 1: Proportion of aneurysms with complete occlusion
时间窗: 18 (±6) months
based on Raymond-Roy occlusion classification (RROC) evaluated by an independent Core laboratory
次要结局
未报告次要终点