Stryker Neurovascular Trevo® Retriever Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,008
- 试验地点
- 80
- 主要终点
- Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score
研究概览
简要总结
The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
详细描述
Trevo Retriever Registry is a prospective, open-label, consecutive enrollment, multi-center, international registry that may enroll a maximum of 2000 patients at up to 100 sites worldwide. Revascularization status will be assessed at the end of the procedure using the modified TICI (Thrombolysis in Cerebral Infarction)score. Additional data collection will include:
- Day 90 mRS assessment
- Day 90 all cause mortality
- Neurological deterioration at 24 hours post procedure, defined as a four or more point increase in the NIHSS score from the baseline score
- Rates of device and procedure related serious adverse events (AEs)
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
- •Subjects experiencing acute ischemic stroke who are eligible for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus
- •Trevo Retriever is the initial mechanical neuro-thrombectomy device used to remove the thrombus
- •Signed Informed Consent obtained
- •Subject willing to comply with the protocol follow-up requirements
- •Anticipated life expectancy of at least 3 months
排除标准
- •The subject is participating in another mechanical neuro-thrombectomy device trial or any other clinical trial where the study procedure or treatment might confound the study end point.
结局指标
主要结局
Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score
时间窗: Post Procedure
The primary end point is revascularization based on modified Thrombolysis in Cerebral Infarction score (mTICI). Per protocol, successful revascularization is defined as having a modified TICI score ≥2b at the end of the procedure. Modified TICI Scale (mTICI Scale) Grade 0 - No Perfusion Grade 1 - Penetration with Minimal Perfusion Grade 2 - Partial Perfusion Grade 2a - Only partial filling (\< 50%) of the entire vascular territory is visualized. Grade 2b - Filling of \> 50% all of the expected vascular territory is visualized, but the filling is slower than normal. Grade 3 - Complete Perfusion
次要结局
- All Cause Mortality(90 days)
- Device and Procedure Related Serious Adverse Events (SAEs)(90 days)
- Neurological Deterioration at 24 Hours(24 hours)
- Modified Rankin Scale (mRS) Assessment at 90 Days(90 days)