Gravity Stroke System for Recanalization of Large Vessel Occlusion Strokes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,000
- 主要终点
- Successful reperfusion
研究概览
简要总结
Supernova and Neutron are endovascular mechanical revascularization devices indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing an acute ischemic stroke within 24 hours of symptom onset or from last known well time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has experienced an Acute Ischemic Stroke due to large intracranial vessel occlusion in at least one of the following intracranial vessels: internal carotid artery (ICA), M1and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral artery.
- •Subject has been or will be treated with Supernova and/or Neutron devices as the initial device used to remove the thrombus
- •Subject is willing to participate in a 90-day follow-up visit.
排除标准
- •Concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm where the study procedure or treatment might confound the results of the registry.
研究组 & 干预措施
Supernova revascularization device
Mechanical thrombectomy with Supernova Stent Retriever
干预措施: Supernova revascularization device (Device)
结局指标
主要结局
Successful reperfusion
时间窗: Day 0 (end of procedure)
Rate of successful reperfusion, defined as modified Thrombolysis in Cerebral Ischemia (mTICI) grade of 2b or higher Grade 0: No reperfusion Grade 3: Complete reperfusion
Symptomatic intracranial hemorrhage
时间窗: sICH measured within 24 (18-36) hours of the procedure
Safety (Rate of symptomatic intracranial hemorrhage (sICH) as measured by the SITS-MOST criteria) The SITS-MOST definition of SICH is a local or remote type II parenchymal haemorrhage within 22 to 36 hours after treatment (or sooner) associated with a ≥ fourpoint deterioration on the NIHSS score from baseline or from the lowest score from baseline to 24 hours, or leading to death.
All-cause mortality
时间窗: All-cause mortality measured at 90 (±14) days
Safety (All-cause mortality)
次要结局
- Percentage of participants with a modified Rankin Scale (mRS) score of ≤2(90 (±14) days post-treatment)
- Asymptomatic Intracranial Hemorrhage(Day 1 (within 24 hours (18-36 hours) of the procedure))
- Neurological Deterioration(Day 1 (within 24 hours (18-36 hours) of the procedure))