Acute ischemic stroke
Conditions
Interventions
Experimental group:Perform mechanical thrombectomy using Shenyi Thrombus Retriever
Control group:Perform mechanical thrombectomy using Solitaire Fr Revascularization Device
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-85 years, subject or their legal guardian agree to sign the informed consent; 2. within 8 hours of the onset of stroke symptoms; 3. ischemic stroke is caused by occlusion of the internal carotid artery or the M1 and M2 segments of MCA and the A1 and A2 segments of the anterior cerebral artery; 4. patients with acute ischemic stroke with large intracranial vascular occlusion and no definite contraindication confirmed by imaging examination; 5. no intracranial hemorrhage (confirmed by imaging examination), and there were no imaging changes of early large area cerebral infarction (the definition of large area cerebral infarction is the aspect score of CT or DWI imaging =70ml or the blood supply area of > 1/3 mca of the infarction area, and the ASPECTS score is shown); 6. score of modified Rankin scale (mRS) before stroke was 0-1; 7. neurological functional symptoms continued unrelieved, 2 points <=NIHSS score < 30 points.
Exclusion criteria
Exclusion criteria: 1) known to be allergic to heparin, anesthetic drugs, contrast agents and/or aspirin, clopidogrel and other antiplatelet drugs; 2) patients with a history of hemorrhagic cerebrovascular disease, active bleeding or a known history of bleeding tendency; 3) uncontrolled hypertension, defined as systolic blood pressure >180mmHg, or diastolic blood pressure >105mmHg, except in patients who can be controlled by continuous injection of antihypertensive drugs; 4) those who are receiving oral anticoagulants or who are prone to bleeding are known to have severe coagulation dysfunction, such as INR > 3 or platelet count < 40x10^9/L; 5) random blood glucose < 2.7mmol/L; 6) patients whose expected survival time was less than 90 days; 7) it is inappropriate to participate in this study if any of the following exclusion criteria appear in the patient's image: - Preoperative CT or MR showed signs of bleeding; - CT or MR shows intracranial mass or tumors requiring surgical treatment; - This angiogram demonstrates carotid dissection, or carotid extracranial occlusion or arteritis; - This angiogram demonstrates an acute simultaneous occlusion of the bilateral carotid system; 8) participate in clinical trials of other drugs or devices within 28 days before screening visit; 9) have heart, lung, liver and kidney failure or other serious diseases; 10) other conditions not suitable for inclusion judged by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| successfully recanalization rate immediatly after surgery (mTICI >=2b (2b or c) will be deem as a successful recanalization); | — |
Secondary
| Measure | Time frame |
|---|---|
| neurological functional independence rate (mRS<=2 will be deem as neurological functional independence) 90 days post surgery;Puncture to recanalization time;Number of mechanical thrombectomy;Rate of distal embolism events;Rate of intraoperative ectopic embolism events;Device performance evaluation; | — |
Countries
China
Contacts
Public ContactJianmin Liu
Shanghai Changhai Hospital
Outcome results
None listed