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.
The 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).
The 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.
Age 18 to 80 years.
Pre-stroke modified Rankin Scale (mRS) score of 0-1.
Baseline NIH Stroke Scale (NIHSS) score between 9 and 17.
Symptom onset to randomization less than 12 hours.
Proximal large vessel occlusion (internal carotid artery or M1 segment) or tandem cervical internal carotid artery stenosis >70%.
Intracranial hemorrhage at baseline imaging.
Pregnancy.
Life expectancy less than 3 months.
Parallel
best medical therapy
Procedure/SurgeryGuideline-based medical management for acute ischemic stroke, including intravenous thrombolysis when clinically indicated according to local and international stroke guidelines.
Endovascular Treatment
Procedure/SurgeryEndovascular 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.
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.
Ordinal Modified Rankin Scale (mRS) Score
Distribution of modified Rankin Scale (mRS, range 0 to 6, lower better) scores
Excellent Functional Outcome (mRS 0-1)
Proportion of participants achieving a modified Rankin Scale (mRS, range 0-6, lower better) score of 0-1.
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.
Infarct Volume
Infarct volume measured by the central imaging core laboratory.
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Hospital Universitari Vall d'Hebron Research Institute
Lead sponsor
University of Iowa
Collaborator
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