EndoVascular Treatment Beyond 24 Hours for AcutE Ischemic Stroke Caused by Anterior Circulation LArge Vessel STEnosis: A Multicenter RandomizeD Controlled Trial(EVT-BELATED)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 432
- 试验地点
- 1
- 主要终点
- Functional independence
研究概览
简要总结
Endovascular therapy (EVT) is currently recommended as the first-line treatment for patients with acute large vessel occlusion (LVO) in the anterior circulation within 24 hours of symptom onset. However, the therapeutic benefit of EVT beyond 24-hour window remains uncertain due to limited evidence. The EVT-BELATED trial is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) study designed to assess the safety and efficacy of EVT in patients with acute ischemic stroke (AIS) caused by anterior circulation LVO presenting beyond 24 hours after symptom onset.
详细描述
This study is a multicenter, prospective, randomized, open-label, blinded end-point (PROBE) trial. Eligible participants will be adults (age >18 years) presenting with acute ischemic stroke (AIS) due to anterior circulation large vessel occlusion (LVO), either with a time window of 24 to 120 hours from symptom onset or last known well or progressive ischemic stroke with a time from symptom onset of 24 hours to 7 days. Participants who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned in a 1:1 ratio to one of two treatment arms. The control group will receive best medical management alone, while the intervention group will receive best medical management in combination with endovascular therapy (EVT). EVT procedures may include mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty, or stenting, as deemed appropriate by the treating physician.
The primary objective of the study is to evaluate the safety and efficacy of EVT in patients presenting with AIS due to anterior circulation LVO beyond 24 hours from symptom onset. The primary endpoint is functional independence at 90 days, defined as a score of 0-2 on the modified Rankin Scale (mRS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Endovascular Treatment plus Best Medical Treatment
Patients in this group will receive endovascular therapy (EVT) plus best medical treatment.
干预措施: Endovascular Treatment (Procedure)
Endovascular Treatment plus Best Medical Treatment
Patients in this group will receive endovascular therapy (EVT) plus best medical treatment.
干预措施: Best Medical Treatment (Drug)
Best Medical Treatment
Patients in this group will receive standard medical therapy in accordance with the guideline-directed management for acute ischemic stroke.
干预措施: Best Medical Treatment (Drug)
结局指标
主要结局
Functional independence
时间窗: 90 ± 7 days
The proportion of patients achieving functional independence, defined as a modified Rankin Scale (mRS) score of 0-2 at 90 ± 7 days. The mRS is a widely used 6-point scale for assessing disability and functional outcomes after stroke, where higher scores represent worse outcomes.
次要结局
- Ordinal distribution of mRS(90 ± 7 days)
- Excellent functional outcome(90 ± 7 days)
- Poor functional outcome(90 ± 7 days)
- Early neurological deterioration(24 ± 12 hours)
- Any neurological improvement(24 ± 12 hours)
- Early neurological improvement(24 ± 12 hours)
- Any new ischemic stroke events(3 months)
- Any ischemic stroke event or revascularization(3-12 months)
研究者
Qi Li
Professor
The Second Hospital of Anhui Medical University