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

November 2, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

284

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Endovascular treatment

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

Other Names:
  • Mechanical thrombectomy
BMT group

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional independence
Time Frame: 90 days follow-up

modified Rankin scale (mRS) of 0-2
90 days follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: within 90 days

Death from any cause
within 90 days
Neurological function
Time Frame: 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
Time Frame: 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)
Time Frame: at 24 ± 12 hours

According to Heidelberg Bleeding Classification, SITS-MOST criteria
at 24 ± 12 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful recanalization rates
Time Frame: 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
Time Frame: during hospitalization

Procedural complications (EVT group)
during hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

115 People's Hospital

Collaborators

Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 2, 2026

First Submitted That Met QC Criteria

November 2, 2026

First Posted (Actual)

November 6, 2026

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 250510703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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