Revive AIS Patients ImmeDiately

Study Overview
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Brief Summary
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This is a multicenter, prospective registry clinical study to evaluate the real-world efficacy and safety of intra-arterial treatment for acute ischemic stroke using Revive SE device on the basis of standardised medical treatment.

Detailed Description
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This is a multi-center, prospective, single-arm observational study to evaluate the real-world efficacy and safety of intra-arterial treatment for acute ischemic stroke patients using Revive SE device on the basis of standardised medical treatment.The device selection before treatment is based upon doctors who are blinded to the protocol. The primary outcomes are reperfusion rate immediately after intervention (mTICI score ≥II b ) and mRS Score at 90 days after intervention.

Official Title
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A Multicenter, Prospective Registry Clinical Study of the Effectiveness and Safety of ReVive SE Thrombectomy for Acute Ischemic Stroke

Conditions
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Ischemic Stroke, Occlusion, Cerebrovascular

Intervention / Treatment
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* Device: Revive SE intracranial thrombectomy device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 18 years; clinical diagnosis should be acute ischaemic stroke; no more than 6 hours after onset; IV tPA thrombolysis, if needed, should start within 4.5 hours after onset； Pre-stroke mRS ≤2; ICA/M1/M2/A1/A2/VA/BA occlusion confirmed by CTA/MRA/DSA;' written informed consent form given Exclusion Criteria: . history of intracranial hemorrhage. . life expectancy <90 days; . history of major surgery or severe trauma in the past 10 days; . Uncontrolled hypertension (defined as: SBP>185mmHg or DBP ≥110 mm Hg at 3 continuous measurements with interval of at least 10 minutes confirm the SBP>185mmHg or DBP ≥110 mm Hg) . PLT<40*10^9/L； . blood glucose <2.7mmol /L or >22. 2 mmol /L； . concomitant use of oral anticoagulation drugs, and INR >3.0； . ASPECTS score ≤5； . conventional angiography indicates poor collateral circulation (ACG Score ≤ 1).

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Revive SE intracranial thrombectomy device|Intra-arterial mechanical thrombectomy with Revive SE； According to patient condition, the investigator could determine intravenous thrombolysis or not at his/her discretion|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reperfusion rate (mTICI≥2b) | The ratio of patients that gained antegrade reperfusion of more than half of the previously occluded target artery ischemic territory | immediately after thrombectomy procedure | 
| Functional outcome | the percentage of functional independence as assessed by mRS (modified Rankin Scale) score<3 | 3 months after thrombectomy procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | the time take to achieve successful reperfusion (from groin puncture to reperfusion) | within 3 hours after groin puncture | 
| Number of passes of ReVive SE for each patient |  | within 3 hours after groin puncture | 
| Incidence of downstream embolization |  | within 3 hours after groin puncture | 
| Incidence of embolization into new territories during intervention |  | within 3 hours after groin puncture | 
| Incidence of symptomatic intracranial hemorrhage |  | within 24 hours after operation | 
| Mortality |  | 3 months | 
| Device or intervention related adverse events |  | within 90 days after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endovascular treatment, mechanical thrombectomy, stent retriever, human