Evaluate the Safety and Efficacy of Thrombectomy System in the Intravascular Treatment of Acute Ischemic Stroke
Acute Ischemic Stroke
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
Eligibility Criteria
Inclusion Criteria: Age 18-85 Within 8 hours of the onset of stroke symptoms There are clinical signs and symptoms consistent with acute ischemic stroke Imaging 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 contraindications 6 points ≤NIHSS score < 30 points Informed consent is signed by the patient or her legal guardian Exclusion Criteria: Known allergies to heparin, narcotic drugs, contrast agents, and/or antiplatelet medications such as aspirin and clopidogrel mRS ≥ 2 before stroke Pregnant Or Lactating Women Hemorrhagic cerebrovascular history within 3 months Refractory 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/L Blood glucose at screening was < 2.8mmol/L or > 22 mmol/L Patients with any of the following exclusion criteria were not eligible to participate in this study Preoperative CT or MRI showed bleeding symptoms CT or MRI shows intracranial mass or intracranial tumor requiring surgical treatment Angiography revealed carotid dissection or extracranial occlusion or arteritis of the carotid artery Angiography revealed simultaneous acute obstruction of both carotid systems Participate in other drug or device clinical trials within 28 days prior to screening visit
Sites / Locations
- Zhangzhou Municipal Hospital of Fujian Province
- Guangdong Provincial People's Hospital
- The First Affiliated Hospital of Jinan University
- Henan Provincial People's Hospital
- Xiangyang Central Hospital
- Xiangyang First People's Hospital
- The first people's hospital of changzhou
- Zhangjiagang First People's Hospital
- The Second People's Hospital of WuxiRecruiting
- The affiliated Hospital of Xuzhou Medical University
- The Second Affiliated Hospital of Nanchang University
- The First Affiliated Hospital of Dalian Medical University
- The affiliated Hospital of Qingdao University
- Changhai Hospital of Shanghai
- Xianyang Hospital of Yan 'an University
- The Second Affiliated Hospital of Zhejiang University School of Medicine
- Jiaxing Second Hospital
- Lishui Municipal Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Mechanical thrombectomy:Thrombectomy system
Intracranial thrombectomy stent :Solitaire FR Revascularization Device
Subjects will be treated with Thrombectomy system,Thrombectomy system is an intraarterial thrombectomy removal device that can be re-inserted into the sheath to restore blood flow by removing blood clots in occluded vessels.
Subjects will be treated with Solitaire FR Revascularization Device ,the Device made by Micro Therapeutics Inc. DBA ev3 Neurovascular