[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657888":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":53,"studyPopulation":42,"armGroups":54,"interventions":67,"overallOfficials":42,"centralContacts":77,"locations":42,"responsibleParty":83,"collaborators":85,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":42,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":111,"overallStatus":128,"whyStopped":42,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":42},{"fullName":5,"class":6},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"Functional Independence at 90 Days","Proportion of participants achieving functional independence, defined as a modified Rankin Scale (mRS, range 0 to 6, lower better) score of 0-2, assessed 90 (±14) days after randomization.","Assessment at 90 (±14) days after randomization",[14,17,20,24,28,32,35,38],{"measure":15,"description":16,"timeFrame":12},"Ordinal Modified Rankin Scale (mRS) Score","Distribution of modified Rankin Scale (mRS, range 0 to 6, lower better) scores",{"measure":18,"description":19,"timeFrame":12},"Excellent Functional Outcome (mRS 0-1)","Proportion of participants achieving a modified Rankin Scale (mRS, range 0-6, lower better) score of 0-1.",{"measure":21,"description":22,"timeFrame":23},"Early Neurological Improvement","Proportion of patients acheiving an early neurological improvemente defined as a reduction in National Institute of Health Stroke Scale (NIHSS, range 0-42, lower better) score of ≥8 points from baseline or an absolute NIHSS ≤2 at 24 hours.","24 hours after randomization",{"measure":25,"description":26,"timeFrame":27},"Infarct Volume","Infarct volume measured by the central imaging core laboratory.","24-48 hours after randomization",{"measure":29,"description":30,"timeFrame":31},"Discharge Disposition","Discharge to home versus rehabilitation or other healthcare facility.","At hospital discharge (up to 15 days from randomization)",{"measure":33,"description":34,"timeFrame":31},"Length of Hospital Stay","Duration of hospitalization measured in days.",{"measure":36,"description":37,"timeFrame":12},"EQ-5D-5L Score","Health-related quality of life assessed by the EQ-5D-5L ((EuroQol 5-Dimension, 5-Level), descriptive system and EQ VAS). Two components will be reported: the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions - mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression - each evaluated from 1 to 5 (no sumatory). A lower level on a dimension indicates better health. EQ VAS (vertical visual analogue scale: ranging from 0 - 100. Higher scores indicate better health)",{"measure":39,"description":40,"timeFrame":41},"Return to Work or Usual Activities","Proportion of participants returning to work or usual daily activities.","Assesement at 90 days (+-14) after randomization",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":46,"primaryPurpose":47,"observationalModel":42,"timePerspective":42,"maskingInfo":48},"RANDOMIZED","PARALLEL","Participants will be randomized in a 1:1 ratio to receive either best medical therapy (BMT) alone or best medical therapy plus endovascular treatment (EVT). The EVT arm follows a standardized stepwise approach consisting of aspiration thrombectomy (ADAPT) followed by SAIL when aspiration is unsuccessful or vascular anatomy is unfavorable.","TREATMENT",{"masking":49,"maskingDescription":50,"whoMasked":51},"SINGLE","This is a prospective, randomized, open-label, blinded endpoint (PROBE) trial. Participants, treating physicians, and interventionalists are aware of treatment allocation. Functional outcomes at 90 days are assessed by trained independent evaluators blinded to treatment assignment. Imaging endpoints are adjudicated by an independent central imaging core laboratory blinded to treatment allocation and clinical outcomes. Whenever feasible, statisticians will remain blinded until database lock.",[52],"OUTCOMES_ASSESSOR","Acute ischemic stroke due to medium and distal vessel occlusions (MeVOs) represents a substantial proportion of ischemic strokes. While endovascular treatment (EVT) is the standard of care for proximal large vessel occlusions, recent randomized trials have not demonstrated a consistent clinical benefit of EVT in MeVO populations. These neutral findings may reflect the heterogeneity of MeVO stroke, variability in patient selection, and differences in vascular anatomy and procedural complexity.\n\nThe SAIL-MEVO trial is an investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint (PROBE) trial designed to evaluate whether optimized EVT improves functional outcomes compared with best medical therapy (BMT) alone in carefully selected patients with acute ischemic stroke due to MeVO.\n\nParticipants aged 18 to 80 years presenting within 12 hours from symptom onset with an isolated distal vessel occlusion (non-dominant M2-M3 middle cerebral artery, A2-A3 anterior cerebral artery, or P2-P3 posterior cerebral artery), baseline NIHSS score between 9 and 17, ASPECTS ≥6, and an AI-predicted infarct core volume \\\u003C10 mL on non-contrast CT will be eligible for enrollment.\n\nParticipants will be randomized in a 1:1 ratio to:\n\nBest medical therapy (BMT) according to current stroke guidelines, including intravenous thrombolysis when indicated; or Best medical therapy plus endovascular treatment (EVT).\n\nThe EVT strategy consists of a standardized stepwise approach. Primary aspiration thrombectomy (ADAPT) will be performed first using a small-caliber distal aspiration catheter. If aspiration is unsuccessful or vascular anatomy prevents adequate catheter access, treatment will proceed using the SAIL technique, consisting of low-profile stent retriever deployment with localized intra-arterial thrombolysis according to the study operations manual.\n\nThe primary efficacy endpoint is functional independence, defined as a modified Rankin Scale (mRS) score of 0-2 at 90 days after randomization.\n\nSecondary efficacy endpoints include ordinal mRS shift, excellent functional outcome (mRS 0-1), early neurological improvement, infarct volume at 24-48 hours, discharge disposition, hospital length of stay, health-related quality of life (EQ-5D-5L), return to work or usual activities, and patient-reported outcome measures.\n\nSafety endpoints include symptomatic intracranial hemorrhage, any intracranial hemorrhage, subarachnoid hemorrhage, embolization to new territory, vessel perforation or dissection, access-site complications, device- or procedure-related serious adverse events, all-cause mortality, and serious adverse events through 90 days.\n\nApproximately 420 participants will be enrolled across up to 10 comprehensive stroke centers. Clinical outcomes will be assessed by investigators blinded to treatment allocation, and imaging endpoints will be adjudicated by an independent central imaging core laboratory. An independent Data and Safety Monitoring Board (DSMB) will oversee participant safety throughout the study.",[55,61],{"label":56,"type":57,"description":58,"interventionNames":59},"Best Medical Therapy (BMT)","ACTIVE_COMPARATOR","Participants receive guideline-based best medical therapy for acute ischemic stroke, including intravenous thrombolysis when indicated according to current clinical guidelines.",[60],"Procedure: best medical therapy",{"label":62,"type":63,"description":64,"interventionNames":65},"Endovascular Treatment Plus Best Medical Therapy (EVT + BMT)","EXPERIMENTAL","Participants receive guideline-based best medical therapy plus endovascular treatment. The endovascular strategy consists of a standardized stepwise approach using aspiration thrombectomy (ADAPT) as the first-line technique, followed by the SAIL technique (low-profile stent retriever with localized intra-arterial thrombolysis) when aspiration is unsuccessful or vascular anatomy is unfavorable.",[60,66],"Procedure: Endovascular Treatment",[68,73],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":42},"PROCEDURE","best medical therapy","Guideline-based medical management for acute ischemic stroke, including intravenous thrombolysis when clinically indicated according to local and international stroke guidelines.",[56,62],{"type":69,"name":74,"description":75,"armGroupLabels":76,"otherNames":42},"Endovascular Treatment","Endovascular treatment using a standardized stepwise protocol. Primary aspiration thrombectomy (ADAPT) is performed first using a small-caliber distal aspiration catheter. When aspiration is unsuccessful or vascular anatomy is unfavorable, treatment proceeds with the SAIL technique, consisting of deployment of a low-profile stent retriever with localized intra-arterial thrombolysis according to the study operations manual.",[62],[78],{"name":79,"role":80,"phone":81,"phoneExt":42,"email":82},"Marc Ribo, MD, PhD","CONTACT","934 89 30 00","marcriboj@hotmail.com",{"type":84,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[86],{"name":87,"class":6},"University of Iowa","100657888","sail-mevo-endovascular-treatment-versus-best-medical-therapy-for-distal-vessel-occlusions-100657888",false,"NCT07843797","SAIL-MEVO: Endovascular Treatment Versus Best Medical Therapy for Distal Vessel Occlusions","SAIL-MEVO: Endovascular Treatment Versus Best Medical Therapy for Distal Vessel Occlusions - Randomized Controlled Trial","SAIL MEVO","Inclusion Criteria:\n\n* Age 18 to 80 years.\n* Pre-stroke modified Rankin Scale (mRS) score of 0-1.\n* Baseline NIH Stroke Scale (NIHSS) score between 9 and 17.\n* Symptom onset to randomization less than 12 hours.\n* Acute ischemic stroke due to an isolated medium\u002Fdistal vessel occlusion involving a non-dominant M2-M3 middle cerebral artery, A2-A3 anterior cerebral artery, or P2-P3 posterior cerebral artery confirmed by CTA or MRA.\n* Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on non-contrast CT AND AI-predicted infarct core volume \\\u003C10 mL on non-contrast CT (when available) AND AI-defined Tmax \\>6s volumen \\>30cc on CTP (when available).\n* Written informed consent obtained from the participant or a legally authorized representative in accordance with local regulations.\n\nExclusion Criteria:\n\n* Proximal large vessel occlusion (internal carotid artery or M1 segment) or tandem cervical internal carotid artery stenosis \\>70%.\n* Intracranial hemorrhage at baseline imaging.\n* Pregnancy.\n* Life expectancy less than 3 months.\n* Severe allergy to iodinated contrast media.","ALL","18 Years","80 Years",{"count":100,"type":101},420,"ESTIMATED","INTERVENTIONAL",[104],"NA","Patients with acute ischemic stroke caused by distal or medium vessel occlusions (MeVOs) may experience significant disability despite receiving the current standard medical treatment. Although endovascular treatment (EVT) is an established therapy for large vessel occlusions, its benefit in MeVO stroke remains uncertain.\n\nThe SAIL-MEVO trial is a prospective, multicenter, randomized controlled trial designed to evaluate whether EVT combined with best medical therapy improves functional outcomes compared with best medical therapy alone in selected patients with acute ischemic stroke due to MeVO. Eligible participants will be randomized in a 1:1 ratio to receive either best medical therapy alone or best medical therapy plus EVT using a standardized stepwise approach consisting of aspiration thrombectomy (ADAPT) followed, when necessary, by the SAIL technique (stent retriever-assisted intra-arterial lysis).\n\nThe primary objective is to determine whether EVT increases the proportion of patients achieving functional independence (modified Rankin Scale score 0-2) at 90 days after stroke. Secondary objectives include assessment of neurological recovery, infarct volume, quality of life, patient-reported outcomes, safety, and procedural outcomes.",[107,108,109,110],"Medium Vessel Occlusion Stroke (MeVO)","Stroke Acute","Acute Ischemic Stroke","Cerebral Artery Occlusion",[112,113,114,74,115,116,117,118,119,120,109,121,122,123,124,125,126,127],"Distal Vessel Occlusion","Medium Vessel Occlusion","MeVO","Mechanical Thrombectomy","Aspiration Thrombectomy","ADAPT","SAIL","Intra-Arterial Thrombolysis","Randomized Controlled Trial","Modified Rankin Scale","NIHSS","AI Imaging","Infarct Core","Neurointervention","Stroke","PROBE Trial","NOT_YET_RECRUITING","2026-09-23",{"date":131,"type":132},"2026-09-28","ACTUAL",{"date":134,"type":101},"2026-10",{"date":136,"type":101},"2029-07",{"name":5,"class":6}]