APERIO® HYBRID Thrombectomy Device for Flow Restoration in Vessels of Patients Experiencing Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Acandis GmbH
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Technical success
研究概览
简要总结
This is a prospective, multicenter, single-arm, open-label, national Post-Market Clinical Follow-up study to collect comprehensive information on technical and clinical success and safety of the use of APERIO® Hybrid(17/21) Thrombectomy Device in clinical practice. APERIO® Hybrid(17/21) Thrombectomy Device will be used within its approved indication.
详细描述
German APERIO® Hybrid Post- Market Clinical Follow-up Study
APERIO® Hybrid PMCF Study- Thrombectomy device for flow restoration in vessels of patients experiencing acute ischemic stroke
Study Type: prospective, multicenter, single-armed, open-label
Participants: 8 participating centers in Germany
PI: Dr. Christian Mathys, Evangelisches Krankenhaus Oldenburg, Germany
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
- •All patients treated with APERIO® HYBRID and/or APERIO® Hybrid(17/21) Thrombectomy Device as a result of an acute stroke.
排除标准
- •Patient age < 18 years
- •Pre stroke mRS ≥ 3
结局指标
主要结局
Technical success
时间窗: until 24 hours after intervention
mTICI ≥ 2b after treatment with APERIO® HYBRID(17/21)
Good clinical outcome at 90 days
时间窗: 90 days after intervention
Modified Rankin Scale (mRS) \< 3 (mRS 1= no symptoms/ good outcome; mRS 6= Patient died/ worse outcome)
Periprocural symptomatic intracranial hemorrhage (sICH):
时间窗: until 24 hours after intervention
ICH in postinterventional (\<24 hours) CT associated with worsening of NIHSS by ≥ 4 points within 24 hours
次要结局
- Cerebrovascular events until hospital discharge:(between 24 hours after intervention and discharge from hospital)
- Cerebrovascular events at 90 days(at 90 days)