A Retrospective Study of Reco Thrombectomy Stent for Intravascular Treatment of Acute Ischemic Stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The time between the onset of the disease and the opening of the blood vessels
研究概览
简要总结
To explore the differences in the green channel process of stroke in various regions of the same province, to target and shorten the time delay of emergency process, and to explore the key technologies of endovascular treatment of acute ischemic stroke. To investigate the use and embolectomy effect of Reco, the first embolectomy stent in China, in economically developed areas. Health economic assessment (cost-benefit analysis) of ischemic stroke patients in various regions of the province.
详细描述
The Reco Embolectomy Stent is indicated for patients who cannot be treated with intravenous tissue activator (IVt-PA) or who have failed IVt-PA therapy and is intended to remove thrombus from a large intracranial vessel in patients with ischemic stroke to restore blood flow.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Patient age ≥18 years
- •The clinical diagnosis was acute ischemic stroke
- •Large vascular lesions were detected by head CT, CTA, MRI, MRA or DSA
- •Preoperative baseline NIHSS score > 4
- •MRS 0-1 before this stroke
- •Mechanical thrombectomy was performed
- •Use Reco thrombectomy bracket
排除标准
- •epileptic seizure
- •Sudden coma
- •Neurological loss symptoms quickly improved
- •Imaging was negative, but clinical symptoms did not rule out subarachnoid hemorrhage
- •Previous intracranial hemorrhage, subarachnoid hemorrhage, and brain tumor (with mass effect)
- •History of head trauma within 3 months prior to surgery
- •History of arterial puncture with difficulty in compression and hemostasis within one week prior to surgery
- •Physical examination revealed evidence of active bleeding or trauma (e.g. fracture)
- •Women are known to be pregnant or breastfeeding
- •Severe allergies to contrast agents are known
结局指标
主要结局
The time between the onset of the disease and the opening of the blood vessels
时间窗: Immediately after surgery
Calculate the time from onset to vessel opening
Functional independence at 90 days (defined as mRS≤2)
时间窗: 90day after surgery
mRS scores were performed 90 days after surgery
Symptomatic intracranial hemorrhage within 24 hours after surgery
时间窗: 24 hours after surgery
Symptomatic intracranial hemorrhage was evaluated by CT 24 hours after operation
次要结局
- Time from onset to admission(Immediately after surgery)
- Time from admission and puncture time(Immediately after surgery)
- Puncture to the time of vessel opening(Immediately after surgery)
研究者
PengYa
Principal Investigator
The First People's Hospital of Changzhou