RECO in the Endovascular Treatment of Acute Ischemic Stroke

Study Overview
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Brief Summary
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Investigate Reco ® ,the first clot retriever in china as the primary therapyand remedies in the real world.

Detailed Description
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Endovascular thrombectomy (EVT) is effective and safe for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) in major clinical trials. Whether the benefit of EVT in randomized trials could be generalized to clinical practice, especially in developing countries, remains unknown. The Registry was established to evaluate the utilization, and subsequent outcomes of EVT treated AIS patients. This study is a multi-center, prospective registry study initiated by researchers, to investigate Reco ® ,the first clot retriever in china as the primary therapyand remedies in the real world.

Official Title
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A Prospective ,Multicenter, Registry Study of RECO in the Endovascular Treatment of Acute Ischemic Stroke

Conditions
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Intracranial Artery Occlusion With Infarction (Disorder)

Intervention / Treatment
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* Device: RECO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Diagnosis of acute ischemic stroke Imaging confirmed intracranial large artery occlusion (LVO): intracranial internal carotid artery (ICA T/L), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1);ASPECT or PC-ASPECT ≥ 6 Initiation of any type of endovascular treatment (EVT), including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, and stenting The patient or the patient's legal representative is able and willing to sign the informed consent Exclusion Criteria: Isolated cervical ICA or VA occlusion; No evidence of LVO on DSA.

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: RECO|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional independence at 90 days (modified Rankin Scale of 0-2) | The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead.A higher score indicates worse a outcome. | [90±7 days after procedure] | 
| Symptomatic intracranial hemorrhage (sICH) within 12-36 hours after the procedure | Heidelberg Bleeding Classification): new intracranial hemorrhage detected by brain imaging associated with ≥4 points total National Institutes of Health Stroke Scale (NIHSS), ≥2 points in one NIHSS category, leading to intubation/ hemicraniectomy/ EVD placement or other major medical/surgical intervention, or absence of alternative explanation for deterioration | 12-36 hours after the procedure | 
| Time from symptom onset to recanalization | Minutes | From the time of symptom onset until the time of of the recanalization of the occluded artery, assessed up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recanalization rate at the end of the procedure | modified thrombolysis in cerebral infarction (mTICI) 2b-3 | Immediately after the procedure | 
| Recanalization rate after the first attempt | mTICI score 2b-3 | Immediately after the first attempt of endovascular treatment | 
| Changes in NIHSS score immediately after the procedure | difference between NIHSS score immediately after the procedure and baseline | within 2 hours after the procedure | 
| Changes in NIHSS score 24 hours after the procedure | difference between NIHSS score 24 hours after the procedure and baseline | 24 hours after the procedure | 
| Changes in NIHSS score 7 days after the procedure or at discharge | difference between NIHSS score 7 days after the procedure or discharge and baseline | 7 days after the procedure or discharge | 
| EQ-5D 90 days after the procedure | EQ-5D is a standardized instrument for measuring generic health status. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).A higher score indicates a better outcome. | 90±7 days after the procedure | 
| Barthel index (BI) 90 days after the procedure | The BI has a score of 0-100. A higher score indicates a better outcome. | 90±7 days after the procedure | 
| Parenchymal hematoma (PH2) | PH2 is defined as the rate of hematoma >30percent in infarct area | 12-36 hours after the procedure | 
| Any intracranial hemorrhage on imaging | Based on the image | 12-36 hours after the procedure | 
| All-cause mortality within 90 days | mortality | 90±7 days after the procedure | 
| Time from onset to arrival | record the time | At baseline, after arrival at the hospital immediately | 
| Time from arrival to imaging | record the time | At baseline, after taking any brain imaging immediately | 
| Time from imaging to puncture | record the time | At baseline, during the procedure, after successful groin puncture immediately | 
| Time from puncture to recanalization | record the time | At baseline, during the procedure, after successful recanalization immediately | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute ischemic stroke, endovascular treatment, registry