SAIL-MEVO: Endovascular Treatment Versus Best Medical Therapy for Distal Vessel Occlusions - Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 420
- 主要终点
- Functional Independence at 90 Days
研究概览
简要总结
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.
详细描述
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.
The 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.
Participants 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 <10 mL on non-contrast CT will be eligible for enrollment.
Participants will be randomized in a 1:1 ratio to:
Best medical therapy (BMT) according to current stroke guidelines, including intravenous thrombolysis when indicated; or Best medical therapy plus endovascular treatment (EVT).
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 单盲 (结局评估者)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 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.
排除标准
- 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.
研究组 & 干预措施
Best Medical Therapy (BMT)
Participants receive guideline-based best medical therapy for acute ischemic stroke, including intravenous thrombolysis when indicated according to current clinical guidelines.
干预措施: best medical therapy (Procedure)
Endovascular Treatment Plus Best Medical Therapy (EVT + BMT)
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.
干预措施: best medical therapy (Procedure)
Endovascular Treatment Plus Best Medical Therapy (EVT + BMT)
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.
干预措施: Endovascular Treatment (Procedure)
结局指标
主要结局
Functional Independence at 90 Days
时间窗: Assessment at 90 (±14) days after randomization
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.
次要结局
- 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))
- Length of Hospital Stay(At hospital discharge (up to 15 days from randomization))
- EQ-5D-5L Score(Assessment at 90 (±14) days after randomization)
- Return to Work or Usual Activities(Assesement at 90 days (+-14) after randomization)
研究者
标识符
- NCT 编号
- NCT07843797
- 其他研究编号
- SAIL-MEVO-RCT-V1.0
日期
- 首次提交
- (2个月前)
- 首次发布
- (前天)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
The patients/representants have signed an informed consent that specifies that no sharing of personal data will be performed.