REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion

Study Overview
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Brief Summary
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The aim of the study was to establish a clinical and advanced imaging database of acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China, and to investigate the predictors and potential mechanisms of futile recanalization after mechanical thrombectomy.

Detailed Description
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The time-window of mechanical thrombectomy for ischemic stroke has extended from 4.5 hours to 24 hours based on the results of the DAWN and DEFUSE 3 trials. However, evidence on the effectiveness and safety of mechanical thrombectomy within 24 hours in the real-world is insufficient. This is a multi-center, prospective, registry cohort study that acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China. A total of 1600 patients with advanced imaging data were anticipated to be enrolled.

Official Title
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REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion

Conditions
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Stroke, Vascular Occlusion, Endovascular Treatment, Mechanical Thrombectomy, Perfusion Imaging

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years; Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombectomy Large vessel occlusion of cerebral anterior circulation (ICA, MCA-M1 or MCA-M2) confirmed by CTA or MRA, planned to receive or received stenting or aspiration thrombectomy Time intervals ≤ 24 hours from stroke onset to groin puncture.(fulfilled the inclusion of DAWN or DEFUSE 3 trial if the time intervals from stroke onset to groin puncture was ≥6 hours) mRS score ≤2 before admission Informed consent obtained for longitudinal enrolled patients, waived of consent for retrospectively included cases Exclusion Criteria: Had a history of infective disease, immunity disease, radiotherapy at head or neck, carotid dissection or other carotid disease. Unable to receive CT or MR scan due to heart failure, cardiac pacemaker, metal implants or claustrophobia, etc. Unable to be injected with contrast agent due to allergy, renal dysfunction, etc. Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months) Already participated in other drug trials

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Favorable functional outcome | proportion of mRS score 0-2 at 3 months. The modified Rankin Scale (mRS) has a minimum value of 0 and maximum value of 6. Higher value indicated worse functional outcome | 3 months from stroke onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excellent functional outcome at 90 days | proportion of mRS score 0-1 at 3 months | 3 months from stroke onset | 
| Ordinal distribution of mRS at 90 days | Number of participants with the ordinal distribution of mRS at 90 days | 3 months from stroke onset | 
| EQ-5D score at at 90 days | EQ-5D score at 3 months. EuroQol Five Dimensions Questionnaire scale (EQ-5D score) has a minimum value of 0 and maximum value of 100. Lower value indicated worse functional outcome | 3 months from stroke onset | 
| Neurological improvement at 24 hours | NIHSS score <=1 or improvement of NIHSS score>=4 compared with baseline NIHSS. National Institution Health Stroke Scale (NIHSS) has a minimum value of 0 and maximum value of 45. Higher value indicated worse severity of neurological impairment. | 24 hours from stroke onset | 
| recanalization post-operation | proportion of eTICI 2b50/2c/3. Thrombectomy is a surgical operation using a retrieve stent or aspiration catheter to remove the thrombus inside an occluded vessel and achieve recanalization.The eTICI is a scale to assess the degree of recanalization. So, once the surgeon thought he completed the thrombectomy, he needed to perform a cerebral angiography to assess the degree of recanalization using eTICI. | (Day 0) immediately the surgeon thought the thrombectomy completed and performed a second cerebral angiography . | 
| recanalization at 24 hours | proportion of eTICI 2b50/2c/3 | 24 hours after thrombectomy completed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, vascular occlusion, endovascular treatment, mechanical thrombectomy, perfusion imaging