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RecruitingNCT07922317ELATEUpdated Nov 6, 2026

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

An observational study in Acute Ichemic Stroke, sponsored by 115 People's Hospital. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by 115 People's Hospital · Observational

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Updated Nov 6, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
284
Ages
18 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

  • Acute Ichemic Stroke

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Keywords

  • Endovascular treatment
  • Large-vessel occlusion
  • Beyond 24-hour
  • Extended time window
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 284 is above the median of 152 across 1,968 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

115 People's Hospital is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (by patient or proxy, according to local requirements)

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
284 participants (estimated)
Target follow-up
90 Days
Patient registry
Yes

Groups and cohorts

  • 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

  • BMT group

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

Interventions

  • ProcedureEndovascular treatment

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

    Also known as: Mechanical thrombectomy

06

What researchers measure

Primary outcomes

  1. Functional independence

    modified Rankin scale (mRS) of 0-2

    Time frame: 90 days follow-up

Secondary outcomes

  1. Neurological function

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

    Time frame: 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.

    Time frame: within the first 72 h

  3. Death

    Death from any cause

    Time frame: within 90 days

  4. Symptomatic intracerebral hemorrhage (sICH)

    According to Heidelberg Bleeding Classification, SITS-MOST criteria

    Time frame: at 24 ± 12 hours

Other outcomes

  1. Successful recanalization rates

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

    Time frame: at the end of the procedure

  2. Procedural complications

    Procedural complications (EVT group)

    Time frame: during hospitalization

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

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

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07922317
Lead sponsor
115 People's Hospital
Collaborators
Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam
Responsible party
Hang Tran (Medical Doctor, Master of Medicine, 115 People's Hospital) — Principal investigator
First posted
Nov 6, 2026
Start date
Jul 6, 2026
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Nov 6, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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