REcanalization of Distal Cerebral Vessels in Acute Stroke Using ApeRio®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Acandis GmbH
- 入组人数
- 134
- 试验地点
- 11
- 主要终点
- Primary Safety endpoint
研究概览
简要总结
The purpose of the REVISAR PMCF is to collect data in clinical practice of the APERIO® and APERIO® Hybrid(17) Thrombectomy Device, which are intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Recanalization status will be assessed at the end of the procedure using the modified TICI (Thrombolysis in cerebral infarction) score.
详细描述
Study Type: prospective, multicenter, single-arm, open-label, national
Participants: 11 participating centers in Germany
PI: Dr. Franziska Dorn, University Hospital Bonn, Germany
Estimated Enrolment: A minimum of 130 patients treated with the APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to thrombotic occlusions in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA)
Follow up: 3 months
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
- •Any patient treated with the APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to occlusion in distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA) according to IFU
- •Age ≥ 18 years
排除标准
- •pre stroke mRS ≥ 3
- •Any contraindication according to IFU
结局指标
主要结局
Primary Safety endpoint
时间窗: 90 days
Mortality
Primary safety endpoint
时间窗: 90 days
Rates of device and procedure related (serious) adverse events ((S)AEs)
Primary efficacy endpoint
时间窗: Immediatley after interventional procedure
Successful arterial recanalization of occluded target vessel measured by mTICI score of 2b or 3 following the use of the APERIO® and APERIO® Hybrid(17) Thrombectomy Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes per Device mTICI describes the response of thrombolytic therapy in ischemic stroke. Higashida et al. 2003: Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal Grade 3: complete perfusion
次要结局
- Good neurological outcome(90 days)