ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window (ELATE)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Hang Tran, M.D
- Telefonnummer: +84778771795
- E-post: minhhangtran93@gmail.com
Studiesteder
-
-
Vietnam
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Ho Chi Minh City, Vietnam, Vietnam, 70000
- Rekruttering
- 115 People'S Hospital
-
Ta kontakt med:
- Huy-Thang Nguyen, PhD
- Telefonnummer: +84909982115
- E-post: nguyenhuythang115@gmail.com
-
Ta kontakt med:
- Hang Tran, M.D
- Telefonnummer: +84778771795
- E-post: minhhangtran93@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
Inclusion Criteria:
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Age ≥ 18 years
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Presentation with acute ischemic stroke within 24 to 72 hours of stroke onset or last known well.
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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)
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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).
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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).
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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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
Andre navn:
|
|
BMT group
Patients who received best medical treatment (BMT) alone without endovascular treatment, managed according to local clinical practice guidelines and physician discretion. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional independence
Tidsramme: 90 days follow-up
|
modified Rankin scale (mRS) of 0-2 |
90 days follow-up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Death
Tidsramme: within 90 days
|
Death from any cause |
within 90 days
|
|
Neurological function
Tidsramme: 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
Tidsramme: 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)
Tidsramme: at 24 ± 12 hours
|
According to Heidelberg Bleeding Classification, SITS-MOST criteria |
at 24 ± 12 hours
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Successful recanalization rates
Tidsramme: 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
Tidsramme: during hospitalization
|
Procedural complications (EVT group) |
during hospitalization
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
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Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
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Oppdateringer av studieposter
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Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 250510703
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-delingstidsramme
Data sharing will be available from 12 months after the publication of the main results.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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