Okami Medical Comprehensive Registry Platform
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Safety Endpoint
研究概览
简要总结
This registry will provide insights into the use of Okami Medical devices in real-world clinical and study effectiveness and safety of Okami Medical devices.
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 patient or their legally authorized representative is willing and able to provide informed consent per local requirements
- •Has or will receive treatment with an eligible Okami Medical device
- •Age ≥ 18 years
排除标准
- •Is or will be inaccessible for registry follow-up
- •Meets exclusion criteria required by local requirements
- •Current or planned participation in a drug or device study that would interfere with participation in this registry or confound the results of this registry in the opinion of the investigator
研究组 & 干预措施
Analysis Population 1
Patients treated for the control of peripheral arterial bleeding/hemorrhage.
干预措施: LOBO Vascular Occlusion System (Device)
Analysis Population 2
Patients treated for pulmonary arteriovenous malformations.
干预措施: LOBO Vascular Occlusion System (Device)
Analysis Population 3
Patients treated with the LOBO Vascular Occlusion System.
干预措施: LOBO Vascular Occlusion System (Device)
结局指标
主要结局
Safety Endpoint
时间窗: 30 days post-index procedure
Incidence of device-related serious adverse events during the index procedure
Effectiveness Endpoint
时间窗: During index procedure
Technical success of the LOBO Vascular Occlusion System defined as occlusion of the intended target(s) with the LOBO occluder, assessed by angiography
次要结局
未报告次要终点