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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 trial, 200 subjects with acute ischemic stroke who met the inclusion criteria and did not meet any exclusion criteria were randomly divided into the test group and the control group at 1:1, and received endovascular therapy with corresponding instruments according to the information of the group and evaluated the results

Official Title
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Prospective, Multicenter, Randomized, Parallel Controlled Study to Evaluate the Safety and Efficacy of Thrombectomy System in the Intravascular Treatment of Acute Ischemic Stroke

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Device: Mechanical thrombectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mechanical thrombectomy:Thrombectomy system<br>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. | Device: Mechanical thrombectomy<br>* Treatment of ischemic stroke patients with Mechanical thrombectomy<br>|
| Active Comparator: Intracranial thrombectomy stent :Solitaire FR Revascularization Device<br>Subjects will be treated with Solitaire FR Revascularization Device ,the Device made by Micro Therapeutics Inc. DBA ev3 Neurovascular | Device: Mechanical thrombectomy<br>* Treatment of ischemic stroke patients with Mechanical thrombectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate postoperative target vessel recanalization (mTICI≥2b) rate | According to 《the recommendations of the Chinese Guidelines for Stroke Prevention and Treatment》 , the therapeutic goal of mechanical thrombectomy is to achieve reperfusion of mTICI≥2b, so as to achieve the best possible functional outcome for patients. Therefore, we selected immediate postoperative target vessel recanalization (mTICI≥2b) rate as the primary efficacy endpoint. | Immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time from puncture to recanalization | The time from onset to recanalization will affect the prognosis of patients, and shorter recanalization time will bring better prognostic effect. Therefore, we chose the time from puncture to recanalization to compare the opening efficiency of the two groups of instruments. | immediately after surgery | 
| The number of thrombectomy | The number of thrombectomy will affect the rate of vascular opening and the mortality of subjects, so we selected the number of thrombectomy as indicators to evaluate the efficiency of the opening of the instrument. | immediately after surgery | 
| the rate of successful vascular recirculation after the first thrombectomy | The number of thrombectomy will affect the rate of vascular opening and the mortality of subjects, so we selected the rate of successful vascular recirculation after the first thrombectomy as indicators to evaluate the efficiency of the opening of the instrument. | immediately after surgery | 
| NIHSS Score | The Assessment of Neurological Deficits (NIHSS score) is a well-established and widely accepted scale for evaluating neurological deficits in stroke patients. Neurological function evaluation (NIHSS score) at one day after endovascular therapy is helpful to predict clinical outcome at 90 days after surgery. A score of 3 is usually considered as the limit. A score of 3 or less indicates a mild stroke, a score of 3-10 is a moderate stroke, and a score of more than 10 is a severe stroke. | 24hours and 7days after surgery | 
| Proportion of patients with an mRS Score of 0-2 at 90 days after surgery | MRS Score, also known as modified Rankin score scale, is a scale used to evaluate the recovery state of neurological function in stroke patients. There are seven levels, level 0: completely asymptomatic. Level 1: Despite symptoms, the patient has no apparent disability and can perform all regular work and activities. Level 2: Mildly disabled, unable to perform all work and activities, but able to handle personal matters without assistance from others. Level 3: moderately disabled, requiring assistance, to walking without assistance. Level 4: Severely disabled, unable to walk without assistance, unable to care for their own needs. Level 5: Severely disabled, bedridden, incontinent, in need of constant care, and in need of multiple round-the-clock attention. Level 6: Dead .The proportion of subjects with mRS Score of 0-2 at 90 days after surgery was selected as the basis for judging the prognosis of subjects. | 3 mouths after surgery | 
| Performance evaluation of the device | Device performance evaluation can help to evaluate the maneuverability of research devices in clinical application.Including the ability of the instrument to reach the lesion, the ability of the instrument to release and deploy smoothly, and the difficulty of the instrument to withdraw | immediately after surgery |