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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window (ELATE)

2026年11月2日 更新者:Hang Tran、115 People's Hospital

Evaluation of Clinical Outcomes Following Endovascular Thrombectomy for Acute Ischemic Stroke With Anterior Large Vessel Occlusion in Extended Time Window (24-72 Hours)

The ELATE study is a prospective, observational study designed to evaluate the clinical outcomes and safety profile of endovascular thrombectomy compared with best medical treatment alone in patients presenting with acute ischemic stroke due to anterior large vessel occlusion within 24 to 72 hours from stroke onset or last known well.

研究概览

地位

招聘中

详细说明

Endovascular thrombectomy (EVT) is an established treatment for patients with acute ischemic stroke (AIS) due to large vessel occlusion (LVO) presenting within 24 hours of stroke onset or last known well (LKW). Although landmark trials such as DAWN and DEFUSE 3 used advanced neuroimaging techniques, including CT perfusion (CTP) and MR perfusion (MRP), to identify eligible patients within 6-24 hours, the role of EVT beyond this time window remains insufficiently investigated. This evidence gap is particularly relevant in low- and middle-income countries (LMICs), including Vietnam, where limited public awareness of stroke symptoms, underdeveloped prehospital emergency medical services, and delays in hospital presentation contribute to a substantial proportion of patients presenting in the very late time window. Furthermore, limited access to advanced neuroimaging may restrict treatment opportunities for patients who could potentially benefit from EVT. Therefore, this prospective observational study aims to evaluate clinical outcomes following endovascular thrombectomy compared with best medical treatment in patients with AIS due to anterior circulation LVO presenting 24-72 hours after stroke onset or LKW. Eligible patients are selected based on clinical and imaging criteria, including significant neurological deficits and evidence of potentially salvageable brain tissue, assessed by either perfusion mismatch on CT or MR perfusion imaging or an ASPECTS-based imaging criterion. The findings may provide further evidence regarding the potential role of EVT in this extended time window and help inform clinical decision-making.

研究类型

观察性的

注册 (估计的)

284

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

All adult patients with acute ischemic stroke due to anterior large vessel occlusion within 24 to 72 hours from stroke onset or last known well.

描述

Inclusion Criteria:

  • Age ≥ 18 years

  • Presentation with acute ischemic stroke within 24 to 72 hours of stroke onset or last known well.

  • Baseline NIHSS ≥ 8 (If patients have NIHSS < 8 at admission and experienced END to an NIHSS score ≥ 8 or higher, they also were included if they were 24 to 72 hours from the LKW at this point)

  • Clinical diagnosis of AIS due to anterior circulation LVO (internal carotid artery (ICA) extracranial or intracranial segment, middle cerebral artery (MCA) M1 and proximal M2 segment) on brain imaging (CTA/MRA).

  • Imaging criteria: must fulfill at least one:

    • 1) Core-penumbra mismatch on CT perfusion (CTP) or MR perfusion (MRP) assessed: infarct core volume ≤ 70mL, mismatch ratio ≥ 1,8 and mismatch volume ≥ 15mL.
    • 2) ASPECTS ≥6 on non-contrast CT or diffusion-weighted imaging (DWI).
  • Written informed consent (by patient or proxy, according to local requirements)

Exclusion Criteria:

  • Intracranial hemorrhage identified by CT or MRI
  • Pre-stroke modified Rankin Score (mRS) score of >2 (indicating previous disability)
  • Any terminal illness such that the patient has a life expectance of less than 1 year.
  • Patients with active cancer and undergoing treatment for cancer are excluded
  • Pregnancy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
EVT group

Patients who underwent endovascular treatment (EVT) in combination with best medical treatment as part of routine clinical care, at the discretion of the treating physician.

This procedure is instrumental in restoring cerebral blood flow by addressing the clot-induced obstruction within brain-supplying blood vessels.

其他名称:
  • 机械取栓
BMT group

Patients who received best medical treatment (BMT) alone without endovascular treatment, managed according to local clinical practice guidelines and physician discretion.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Functional independence
大体时间:90 days follow-up

modified Rankin scale (mRS) of 0-2

90 days follow-up

次要结果测量

结果测量
措施说明
大体时间
Death
大体时间:within 90 days

Death from any cause

within 90 days
Neurological function
大体时间:at 24 hours and 7 days (or at discharge)

Measured by scores on the National Institute of Health Stroke Scale (NIHSS)

at 24 hours and 7 days (or at discharge)
Early neurological deterioration
大体时间:within the first 72 h

Clinical worsening that was higher by ≥4 points than the value at baseline during the first 72 h after ischaemic stroke.

within the first 72 h
Symptomatic intracerebral hemorrhage (sICH)
大体时间:at 24 ± 12 hours

According to Heidelberg Bleeding Classification, SITS-MOST criteria

at 24 ± 12 hours

其他结果措施

结果测量
措施说明
大体时间
Successful recanalization rates
大体时间:at the end of the procedure

Proportion of patients achieving mTICI score of 2b/3 (EVT group)

at the end of the procedure
Procedural complications
大体时间:during hospitalization

Procedural complications (EVT group)

during hospitalization

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月6日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年11月2日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月6日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 250510703

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 共享时间框架

Data sharing will be available from 12 months after the publication of the main results.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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