Evaluate the Safety and Efficacy of Thrombectomy System in the Intravascular Treatment of Acute Ischemic Stroke

Through the implementation of prospective, multi-center, randomized, parallel controlled clinical studies to verify the safety and effectiveness of Hongyuan thrombolysis device system in the intravascular treatment of acute ischemic stroke. According to the requirements of the experiment, 200 subjects were selected and randomly divided into the experimental group and the control group 1:1. According to the information of the group, corresponding devices were used to receive endovascular therapy and the results were evaluated.

Inclusion Criteria:Age 18-85Within 8 hours of the onset of stroke symptomsThere are clinical signs and symptoms consistent with acute ischemic strokeImaging examination excluded intracranial hemorrhage, and there were no imaging changes of early large cerebral infarction (large infarction was defined as the aspect score of CT or DWI image < 6, infarct volume ≥70ml or infarct area > 1/3MCA)Patients with imaging evidence of stroke caused by occlusion of the internal carotid artery (intracranial segment) or the M1/M2 segment of the middle cerebral artery or the A1/A2 segment of the anterior cerebral artery without clear contraindications6 points ≤NIHSS score < 30 pointsInformed consent is signed by the patient or her legal guardianExclusion Criteria:Known allergies to heparin, narcotic drugs, contrast agents, and/or antiplatelet medications such as aspirin and clopidogrelmRS ≥ 2 before strokePregnant Or Lactating WomenHemorrhagic cerebrovascular history within 3 monthsRefractory hypertension that cannot be controlled by medication (systolic blood pressure ≥185mmHg, or diastolic blood pressure ≥110mmHg)Bleeding prone predisposition with severe coagulopathy, such as INR > 3.0 or platelet count < 40x10∧9/LBlood glucose at screening was < 2.8mmol/L or > 22 mmol/LPatients with any of the following exclusion criteria were not eligible to participate in this studyPreoperative CT or MRI showed bleeding symptomsCT or MRI shows intracranial mass or intracranial tumor requiring surgical treatmentAngiography revealed carotid dissection or extracranial occlusion or arteritis of the carotid arteryAngiography revealed simultaneous acute obstruction of both carotid systemsParticipate in other drug or device clinical trials within 28 days prior to screening visit