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SAIL-MEVO: Endovascular Treatment Versus Best Medical Therapy for Distal Vessel Occlusions
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Summary
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.
Official title: SAIL-MEVO: Endovascular Treatment Versus Best Medical Therapy for Distal Vessel Occlusions - Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
420
Start Date
2026-10
Completion Date
2029-07
Last Updated
2026-09-28
Healthy Volunteers
No
Conditions
Interventions
best medical therapy
Guideline-based medical management for acute ischemic stroke, including intravenous thrombolysis when clinically indicated according to local and international stroke guidelines.
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.