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Acute Ichemic StrokeELATENCT07922317

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

An observational study of Acute Ichemic Stroke, run by 115 People's Hospital at 1 site in Vietnam.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Acute Ichemic Stroke
What is being tested?
Endovascular treatment
Type of treatment
Surgery or procedure
How many people
284 participants
Where
1 siteVietnam
Study dates
6 Jul 2026to 31 Dec 2028
How long will I take part?
90 Days
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vietnam1 site, 1 recruiting
  • 115 People'S Hospital

    Ho Chi Minh City, Vietnam, 70000

    Hang Tran, M.D, +84778771795, minhhangtran93@gmail.com

    Huy-Thang Nguyen, PhD, +84909982115, nguyenhuythang115@gmail.com

    Recruiting

Other trials in Vietnam

About this study

Official title: 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.

Read the 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.

Being tested
Endovascular treatment
Keywords
Endovascular treatment, Large-vessel occlusion, Beyond 24-hour, Extended time window

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovascular treatmentProcedure or surgery

    Also called Mechanical thrombectomy

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

Study groups in NCT07922317
Study groupRoleWhat they receive
EVT groupPatients who underwent endovascular treatment (EVT) in combination with best medical treatment as part of routine clinical care, at the discretion of the treating physician.
Receives: Procedure: Endovascular treatment
BMT groupPatients who received best medical treatment (BMT) alone without endovascular treatment, managed according to local clinical practice guidelines and physician discretion.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional independence

    modified Rankin scale (mRS) of 0-2

    Measured: 90 days follow-up

Secondary outcomes (4)
  1. Neurological function

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

    Measured: at 24 hours and 7 days (or at discharge)

  2. Early neurological deterioration

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

    Measured: within the first 72 h

  3. Death

    Death from any cause

    Measured: within 90 days

  4. Symptomatic intracerebral hemorrhage (sICH)

    According to Heidelberg Bleeding Classification, SITS-MOST criteria

    Measured: at 24 ± 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study start6 Jul 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
284 participants (estimated)
Target duration
90 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07922317
Sponsor's protocol ID
250510703
Acronym
ELATE
Status last verified
Jul 2026
First submitted
2 Nov 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Albers GW. Late Window Paradox. Stroke. 2018 Mar;49(3):768-771. doi: 10.1161/STROKEAHA.117.020200. Epub 2018 Jan 24. No abstract available.

    PubMed 29367336
  • Sarraj A, Kleinig TJ, Hassan AE, Portela PC, Ortega-Gutierrez S, Abraham MG, Manning NW, Siegler JE, Goyal N, Maali L, Blackburn S, Wu TY, Blasco J, Renu A, Sangha NS, Arenillas JF, McCullough-Hicks ME, Wallace A, Gibson D, Pujara DK, Shaker F, de Lera Alfonso M, Olive-Gadea M, Farooqui M, Vivanco Suarez JS, Iezzi Z, Khalife J, Lechtenberg CG, Qadri SK, Moussa RB, Abdulrazzak MA, Almaghrabi TS, Mir O, Beharry J, Krishnaiah B, Miller M, Khalil N, Sharma GJ, Katsanos AH, Fadhil A, Duncan KR, Hu Y, Martin-Schild SB, Tsivgoulis GK, Cordato D, Furlan A, Churilov L, Mitchell PJ, Arthur AS, Parsons MW, Grotta JC, Sitton CW, Ribo M, Albers GW, Campbell BCV. Association of Endovascular Thrombectomy vs Medical Management With Functional and Safety Outcomes in Patients Treated Beyond 24 Hours of Last Known Well: The SELECT Late Study. JAMA Neurol. 2023 Feb 1;80(2):172-182. doi: 10.1001/jamaneurol.2022.4714.

    PubMed 36574257
  • Albers GW, Marks MP, Kemp S, Christensen S, Tsai JP, Ortega-Gutierrez S, McTaggart RA, Torbey MT, Kim-Tenser M, Leslie-Mazwi T, Sarraj A, Kasner SE, Ansari SA, Yeatts SD, Hamilton S, Mlynash M, Heit JJ, Zaharchuk G, Kim S, Carrozzella J, Palesch YY, Demchuk AM, Bammer R, Lavori PW, Broderick JP, Lansberg MG; DEFUSE 3 Investigators. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N Engl J Med. 2018 Feb 22;378(8):708-718. doi: 10.1056/NEJMoa1713973. Epub 2018 Jan 24.

    PubMed 29364767
  • Kim BJ, Menon BK, Kim JY, Shin DW, Baik SH, Jung C, Han MK, Demchuk A, Bae HJ. Endovascular Treatment After Stroke Due to Large Vessel Occlusion for Patients Presenting Very Late From Time Last Known Well. JAMA Neurol. 2020 Aug 10;78(1):21-9. doi: 10.1001/jamaneurol.2020.2804. Online ahead of print.

    PubMed 32777014
  • Kobeissi H, Ghozy S, Adusumilli G, Kadirvel R, Brinjikji W, Rabinstein AA, Kallmes DF. Endovascular Therapy for Stroke Presenting Beyond 24 Hours: A Systematic Review and Meta-analysis. JAMA Netw Open. 2023 May 1;6(5):e2311768. doi: 10.1001/jamanetworkopen.2023.11768.

    PubMed 37140919
  • Nguyen TN, Abdalkader M, Nagel S, Qureshi MM, Ribo M, Caparros F, Haussen DC, Mohammaden MH, Sheth SA, Ortega-Gutierrez S, Siegler JE, Zaidi S, Olive-Gadea M, Henon H, Mohlenbruch MA, Castonguay AC, Nannoni S, Kaesmacher J, Puri AS, Seker F, Farooqui M, Salazar-Marioni S, Kuhn AL, Kaliaev A, Farzin B, Boisseau W, Masoud HE, Lopez CY, Rana A, Kareem SA, Sathya A, Klein P, Kassem MW, Ringleb PA, Cordonnier C, Gralla J, Fischer U, Michel P, Jovin TG, Raymond J, Zaidat OO, Nogueira RG. Noncontrast Computed Tomography vs Computed Tomography Perfusion or Magnetic Resonance Imaging Selection in Late Presentation of Stroke With Large-Vessel Occlusion. JAMA Neurol. 2022 Jan 1;79(1):22-31. doi: 10.1001/jamaneurol.2021.4082.

    PubMed 34747975
  • Nguyen TQ, Tran MH, Phung HN, Nguyen KV, Tran HTM, Walter S, Hoang DCB, Pham BN, Truong ALT, Tran VT, Nguyen TN, Pham AL, Nguyen HT. Endovascular treatment for acute ischemic stroke beyond the 24-h time window: Selection by target mismatch profile. Int J Stroke. 2024 Mar;19(3):305-313. doi: 10.1177/17474930231208817. Epub 2023 Nov 3.

    PubMed 37807200
  • Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.

    PubMed 29129157

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Ichemic Stroke, run by 115 People's Hospital at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hang Tran, M.D (+84778771795, minhhangtran93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional independence (time frame: 90 days follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07922317, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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