Trevo® Retriever Registry (China)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 10
- 主要终点
- the Modified TICI(Thrombolysis in Cerebral Infarction) Scale at the End of Procedure
研究概览
简要总结
Trevo® Retriever Registry (China) is to assess real world performance of the FDA cleared Trevo Retriever intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke in China.
详细描述
Trevo Registry (China) is a prospective, open-label, multi-center study, and it is the first Stryker China trial. This trial assesses real world performance of the Trevo® Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in subjects experiencing ischemic stroke. Total of 200 subjects among up to 15 sites in China local will participate in this trial. The primary endpoint is revascularization status assessment at the end of the procedure using the modified TICI score.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subjects experiencing acute ischemic stroke due to a large vessel occlusion who are eligible and suitable for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus
- •Trevo Retriever is planned to be the primary mechanical neuro-thrombectomy device to remove the thrombus
- •Subject or subject's legally authorized Representative (LAR) has signed the study Informed Consent Form
- •Subject willing to comply with the protocol follow-up requirements
排除标准
- •Any known coagulopathy
- •Anticipated life expectancy less than 3 months
- •Known absolute contraindications to the use of required study medications or agents (e.g., heparin, aspirin, clopidogrel, radiographic contrast agents, etc.)
- •Preexisting neurological or psychiatric disease that would prevent complete the study required evaluations
- •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
the Modified TICI(Thrombolysis in Cerebral Infarction) Scale at the End of Procedure
时间窗: At the end of the neuro-thrombectomy procedure (Day 1)
The primary endpoint is measured using the modified TICI scale at the end of procedure.Success of primary endpoint was defined as a modified TICI score of 2b or better at the end of procedure. Primary endpoint will be analyzed by percentages, frequencies and the 95% confidence interval of the percentage of success. The 95% confidence interval will be calculated using ClopperPearson exact method. Note: Modified TICI score has 6 grades: 0(No Perfusion), 1(Penetration with Minimal Perfusion), 2(Partial Perfusion), 2a(Partial filling with \<50% of the entire vascular territory is visualized), 2b(Partial filling with ≥50% of the entire vascular territory is visualized), 3(Complete Perfusion). Higher scores mean a better outcome.
次要结局
- Rate of Study Device and Procedure Related SAE Through Day 90(Day 90)
- Day 90 Mortality(Day 90)
- Day 90 mRS(Day 90)
- Neurological Deterioration(24 hours)