Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment

Study Overview
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Brief Summary
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To determine the safety and efficacy of in situ ischemic postconditioning immediately after successful reperfusion in AIS patients underwnet EVT.

Detailed Description
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For acute ischemic stroke (AIS) patients with large vessel occlusion in the anterior circulation receieved successful reperfusion, in situ ischemic postconditioning (ISIPC) was performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation.

Official Title
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Oriental Research Alliance of Acute Ischemic Stroke Given Endovascular Treatment: Technique Feasibility, Safety and Neuroprotective Effects of in Situ Ischemic Postconditioning in Patients Underwent Successful Endovascular Thrombectomy

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Procedure: rapid local ischemic postconditioning (RL-IPostC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (age ≥ 18 to 95 years) patients with an occlusion of the internal carotid artery or M1 or M2 segment of the middle cerebral artery,; Patients with a score of at least 6 on the National Institutes of Health Stroke Scale (NIHSS) at admission and a score of 0 or 1 on the modified Rankin scale before the onset of stroke; Patients with a score of at least 6 on the Alberta Stroke Program Early CT score (ASPECTS) value; Baseline multimodal-CT imaging, including NCCT, CTA and CTP, performed at the trial-site hospital The modified thrombolysis in cerebral infarction (mTICI) scale 2b to 3 achieved in the infarct-related artery after the last thrombectomy attempt Exclusion Criteria: Stoke of large artery atherosclerotic origin or other determined factors (such as dissection) or tandem occlusion; Patients underwent rescue angioplasty or stenting after thrombectomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rapid local ischemic postconditioning (RL-IPostC) group<br>RL-IPostC is performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation. | Procedure: rapid local ischemic postconditioning (RL-IPostC)<br>* with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation<br>|
| control group<br>no intervention was provided after successful reperfusion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional independence | mRS 0-2 | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| excellent functional independence | mRS 0-1 | 3 month | 
| early therapeutic response | defined as a decrease in the NIHSS score of ≥10 from baseline or an NIHSS score of 0 or 1 | on day 5, 6, or 7 of hospitalization or at discharge if it occurred before day 5 | 
| Mortality | Mortality of 3 month after stoke onset | 3 month | 
| hemorrhagic transformation | according to European Cooperative Acute Stroke Study II criteria | 24 hours after treatment | 
| Symptomatic intracerebral hemorrhage (sICH) | an increase of ≥4 points on the National Institutes of Health Stroke Scale (NIHSS) according to Heidelberg Bleeding Classification | 24 hours after treatment | 
| malignant infarction | defined as infarct lesions with significant space-occupying mass effect with over 1/2 affected middle cerebral artery territory with imaging signs of herniation and/or and clinical signs of herniation requiring decompressive hemicraniectomy and/or leading to death due to direct implications of stroke | 24 hours after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke, thrombectomy, thrombolysis, outcome