SAIL-MEVO: Endovascular Treatment Versus Best Medical Therapy for Distal Vessel Occlusions

NCT07843797 | Not Yet Recruiting DMC

• 1 other identifier: SAIL-MEVO-RCT-V1.0
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Medium Vessel Occlusion Stroke (MeVO); Stroke Acute; Acute Ischemic Stroke; Cerebral Artery Occlusion

Keywords

Distal Vessel Occlusion; Medium Vessel Occlusion; MeVO; Endovascular Treatment; Mechanical Thrombectomy; Aspiration Thrombectomy; ADAPT; SAIL; Intra-Arterial Thrombolysis; Randomized Controlled Trial; Acute Ischemic Stroke; Modified Rankin Scale; NIHSS; AI Imaging; Infarct Core; Neurointervention; Stroke; PROBE Trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Ordinal Modified Rankin Scale (mRS) Score

  Assessment at 90 (±14) days after randomization

• Excellent Functional Outcome (mRS 0-1)

  Assessment at 90 (±14) days after randomization

• Early Neurological Improvement

  24 hours after randomization

• Infarct Volume

  24-48 hours after randomization

• Discharge Disposition

  At hospital discharge (up to 15 days from randomization)

Study Arms (2)

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.

Procedure: best medical therapy

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.

Procedure: best medical therapy; Procedure: Endovascular Treatment

Interventions

best medical therapy PROCEDURE

Guideline-based medical management for acute ischemic stroke, including intravenous thrombolysis when clinically indicated according to local and international stroke guidelines.

Best Medical Therapy (BMT); Endovascular Treatment Plus Best Medical Therapy (EVT + BMT)

Endovascular Treatment PROCEDURE

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.

Endovascular Treatment Plus Best Medical Therapy (EVT + BMT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Acute ischemic stroke due to an isolated medium/distal 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.
• Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on non-contrast CT AND AI-predicted infarct core volume \<10 mL on non-contrast CT (when available) AND AI-defined Tmax \>6s volumen \>30cc on CTP (when available).
• Written informed consent obtained from the participant or a legally authorized representative in accordance with local regulations.

You may not qualify if:

• 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.
• Severe allergy to iodinated contrast media.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• University of Iowa: collaborator

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Marc Ribo, MD, PhD

CONTACT

934 89 30 00; marcriboj@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: September 28, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share