Michigan Initial Experience Using Tigertriever for Thrombectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale
研究概览
简要总结
The purpose of this research study is to collect data about the effectiveness (i.e. how the device works) and safety (how safe it is to use such a device) of the Tigertriever in restoring blood flow by removing thrombus (or blood clot) from a large intracranial vessel (blood vessel in the brain) in patients experiencing ischemic stroke within 8 hours of symptom onset.
详细描述
You have been asked to take part in a research study because you have recently been admitted for large vessel occlusion (LVO) and are being treated by Tigertriever.
The treatment is a standard of care (SOC), and if you agree to take part in this study, your participation will include an additional study visit after 3 months. Your study visit will take place at Henry Ford Hospital Neurology or respective collaborator.
For some research studies, such as the one you are being asked to join, it is important that you do not learn the results of certain tests. Whether you intend it or not, sometimes learning this information may make you change your actions and behaviors in ways that could impact the outcome of the study.
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
- •Patients admitted with large vessel occlusion (LVO) and treated with the Tigertriever, as per the approved indication.
- •Tigertriever was used as the first line treatment in the target vessel.
- •A signed informed consent.
排除标准
- •Evidence of acute brain hemorrhage on NCCT or MR at admission.
- •Prior hemorrhage, stroke, thrombolysis, and/or endovascular therapy in the last 3 months.
- •3. pre-stroke disability (pre-stroke mRS ≥ 2).
研究组 & 干预措施
Thrombectomy Treated Patients
Patients are enrolled only if the use of the Tigertreiver is used during surgery.
干预措施: Mechanical Thrombectomy (Procedure)
结局指标
主要结局
Modified Rankin Scale
时间窗: From enrollment to 90 days post treatment
Percentage of participants with a modified Rankin Scale (mRS) score ≤2
Primary Effectiveness Endpoint
时间窗: By the end of the thrombectomy procdure.
Percentage of participants with a mTICI Score ≥IIb
Primary Effectiveness Endpoint - mTICI
时间窗: From time of event to after the first thrombectomy pass.
Percentage of participants with a mTICI Score ≥IIb after the first pass
次要结局
未报告次要终点
研究者
Alex Chebl
Principal Investigator
Henry Ford Health System