NCT04973332已完成不适用
A Prospective, Multicenter, Randomized Controlled, Non-inferiority Study to Investigate the Effectiveness and Safety of Intracranial Embolization Stents for Endovascular Treatment of Acute Ischemic Stroke
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 14
- 主要终点
- Number of Participants With Successful Immediate Recanalization
研究概览
简要总结
A prospective, multicenter, randomized controlled, non-inferiority study to investigate the effectiveness and safety of SINOMED SR for endovascular treatment of acute ischemic stroke
详细描述
This is a multicenter, prospective, randomized, 1:1, controlled trial with blinded outcome assessment assessing non-inferiority of SINOMED SR compared to Solitaire FR. The trial aims to randomize 220 patients 1:1 to receive SINOMED SR or Solitaire FR.The primary outcome is the Success rate of immediate recanalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •General inclusion criteria：
- •18 years old or more;
- •NIHSS≥6 during randomization;
- •Pre-onset MRS < 2;
- •Acute ischemic stroke was diagnosed;
- •Within 24 hours from the onset of stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed;The time point of stroke onset was defined as the time point at which the patient's last normal condition was known;
- •The subject (or his/her guardian) agrees to participate in this study and signs the informed consent.
- •Image inclusion criteria：
- •When it is less than 6h (inclusive) from the onset of stroke to the completion of femoral artery puncture, patients should be examined by cranial CT or MR;
- •When it is more than 6h but less than 24h (inclusive) from the onset of stroke to the completion of femoral artery puncture, brain CT or MR should be performed and Aspects ≥6 points should be satisfied.(If immediate CT perfusion imaging or MR perfusion imaging is feasible, CTP or MRP is recommended to assist in the assessment of the infarct core, and Aspects ≥6 points shall also be satisfied);
- •DSA angiography showed acute intracranial arterial occlusion, including intracranial segment of internal carotid artery (C4-C7), middle cerebral artery (M1/M2), basilar artery and intracranial segment of vertebral artery (V4).
排除标准
- •Neither MRI nor CT can be performed;
- •Hemorrhagic stroke or major ischemic stroke within 6 months before enrollment;
- •Severe persistent hypertension that cannot be controlled by venous hypotension, i.e., patients with SBP persistent >185mmHg and/or DBP persistent >110mmHg;
- •Suppose septic emboli or suspected bacterial endocarditis;
- •Renal failure, defined as: creatinine >3.0mg/dL(264 mol/L);
- •Blood glucose < 2.78mmol/L (50mg/dL) or >22.20mmol/L (400mg/dL);
- •decreased platelet count (< 40×109/L);
- •Known bleeding tendency, defect of coagulation factor, taking anticoagulants and INR > 3.0;
- •Pregnant or lactating women;
- •known to be severely allergic to contrast agents and known to be allergic to nickel materials;
- •The presence of diseases that may affect the assessment of neurological function (such as neurological diseases, mental diseases, etc.);
- •with heart, lung, liver function failure or other serious diseases to interventional surgery;
- •Participating in clinical trials of other drugs or devices;
- •Life expectancy less than 6 months;
- •Other conditions judged by the researcher to be unsuitable for inclusion.
- •Image exclusion criteria：
- •CT or MR imaging evidence of intracranial hemorrhage or known bleeding tendency;
- •CT/MR/DSA showed > occlusion (such as bilateral internal carotid artery occlusion at the same time, or anterior circulation and posterior circulation intracranial vessels occlusion at the same time, or internal carotid intracranial and extracranial segments occlusion at the same time);
- •Carotid artery dissection, carotid initial occlusion or arteritis;
- •The vascular circuitry was severe, and the intracranial thrombectomy stent was difficult to reach the target position.
研究组 & 干预措施
Thrombectomy-SINOMED SR
Experimental
Patients diagnosed with acute ischemic stroke within 24 hours from the onset of the stroke to the completion of femoral artery puncture, regardless of whether intravenous thrombolysis has been performed. Intracranial thrombectomy stents can be used to remove the thrombus in the large vessels of the brain in patients with ischemic stroke To restore blood flow.
干预措施: Intracranial thrombectomy stent (Device)
Thrombectomy-Solitaire FR
Active Comparator
Intracranial thrombectomy was performed with a control product（name:Solitaire FR）
干预措施: Intracranial thrombectomy stent (Device)
结局指标
主要结局
Number of Participants With Successful Immediate Recanalization
时间窗: Within 24 hours post-procedure
The criteria for successful immediate recanalization were target recanalization with a mTICI grade of 2b or 3 grade
次要结局
- Number of Participants Who Died Within 90 Days(within 90 days)
- Number of Participants With a Modified Rankin Scale (mRS) Score of 0-2 Points at 90 Days After Surgery(pre-procedure, and 90 days post-procedure)
- Vascular Recanalization Time(intra-operative)
- The National Institute of Health Stroke Scale Score Decreased the Rate of Subjects With > 4 Points(7 days post-procedure)
- Number of Devices Successfully Operated(intra-operative)
- Number of Participants Who Experienced Symptomatic Intracranial Hemorrhage Within 24 h Post-procedure(within 24 hours post-procedure)
- Number of Device Defects(intra-operative)
- Number of Participants With Serious Adverse Events (SAE)(Within 90 days post-procedure)
- Number of Participants With Adverse Events (AE)(Within 90 days post-procedure)
研究者
研究点 (14)
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