NCT06215105Enrolling By Invitation不适用
Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices
Microvention-Terumo, Inc.5 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2024年1月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 750
- 试验地点
- 5
- 主要终点
- RROC
研究概览
简要总结
To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of commercially available MicroVention devices used for the endovascular treatment of intracranial aneurysms (IA) at the direction of the treating physician.
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
- 是
入选标准
- •Patient must have a single ruptured or unruptured IA for which endovascular treatment has been determined appropriate.
- •Patient's IA will be treated 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 CAR study and prior to enrollment.
- •Note: For the purposes of this protocol, ancillary/accessory devices such as balloon catheters and other access devices are not considered primary treatment devices.
- •Patient or patient 's legally authorized representative (LAR) has provided written informed consent prior to treatment or no later than 48 hours post procedure for emergent treatment of a ruptured aneurysm.
- •Patient must be considered by the treating physician to be available for and able to complete study follow-up visits.
排除标准
- •Target aneurysm has been previously treated via surgical or endovascular means.
- •Patient is enrolled in another device or drug study in which participation could confound study results.
- •Patient has a life expectancy of less than 1 year due to other illness or condition (in addition to an intracranial aneurysm).
- •Patient has been previously enrolled into this study.
结局指标
主要结局
RROC
时间窗: 1 year
Angiographic aneurysm occlusion (RROC) at 1 year without rebleed (ruptured aneurysms only) or retreatment for residual aneurysm
次要结局
未报告次要终点
研究者
研究点 (5)
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