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Endovascular Treatment for Acute Large Vessel Occlusion With Ultra-Large Ischemic Core (LARGE CORE-MT)

25. August 2026 aktualisiert von: First Affiliated Hospital of Harbin Medical University

Endovascular Treatment for Acute Large Vessel Occlusion With Ultra-Large Ischemic Core: A Prospective, Multicenter, Randomized, Open-label, Blinded Endpoint Trial (LARGE CORE-MT)

an investigator initiated, prospective, multicenter, randomized, open-label, blinded endpoint trial (PROBE)

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The primary objective is to determine whether EVT combined with BMM, compared with BMM alone, improves functional outcome in patients with intracranial LVO in anterior circulation and ultra large-core treated within 24 hours of symptom onset.

Primary Efficacy Endpoint Analysis The primary efficacy endpoint is the mRS score at 90 days after randomization. The proportional odds assumption will be formally assessed. If this assumption holds (score test p-value > 0.05), the primary effect measure is the common odds ratio (cOR), which will be estimated using an ordinal logistic regression model to assess the shift in the overall distribution of the mRS scale at 90 days. The model will be adjusted for known prognostic factors including baseline ASPECTS score, age, NIHSS score at admission, and intravenous thrombolysis, as well as the randomization stratification factor, i.e., time from stroke onset or last known well to randomization (≤6 hours vs. >6 hours). Unadjusted cOR estimates and confidence intervals (CI) will also be reported. If the assumption is violated, the generalized odds ratio (GenOR) and its 95% CI will be derived as a robust alternative measure of treatment effect.

Secondary Efficacy Endpoints Analysis For the secondary endpoint of mRS score at 180 days after randomization, the same analysis method as for the primary endpoint will be used. For the proportions of mRS 0-2 and mRS 0-3 at 90 days and 180 days, early neurological improvement, a modified Poisson regression model will be used, reporting Risk Ratio and 95% CI, with the same adjustment factors as in the primary endpoint analysis. For the comparison of EQ-5D-5L score at 90 days between two arms, a linear regression model will be used to estimate the mean difference and 95% CI. For the change in infarct volume from baseline assessed by NCCT at 7 (±1) days or discharge (whichever occurs earlier), or by MRI at 36 (±12) hours after randomization, a linear regression model will be used to estimate the mean difference and 95% CI, with treatment group as the study variable and baseline measurement as a covariate; if normality assumptions are violated, the win ratio method will be used.

Safety Analysis For the primary safety endpoint of all-cause mortality within 90 days after randomization, the Chi-squared test or Fisher's exact test will be used for between-group comparison. For the secondary safety endpoints, including incidence of sICH within 24 hours from onset, proportion of early neurological deterioration, procedure- or device-related complications, and serious adverse events adjudicated by the Clinical Events Committee, data summary will be performed by treatment group.

Studientyp

Interventionell

Einschreibung (Geschätzt)

450

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Hei Longjiang
      • Harbin, Hei Longjiang, China, 150001
        • he First Affiliated Hospital of Harbin Medical University
        • Kontakt:
        • Hauptermittler:
          • Huaizhang SHi, M.D., Ph.D.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  1. ≥18 years.
  2. Symptoms onset or Time last known well ≤ 24 h from randomization.
  3. Acute ischemic stroke due to an occlusion of the intracranial internal carotid artery, M1 or proximal M2 segment of the middle cerebral artery confirmed by CTA or MRA.
  4. NCCT or diffusion-weighted imaging (DWI) demonstrating ASPECTS ≤ 2 or infarct core volume (defined as rCBF <30% on CTP) ≥ 100 mL.
  5. Selection imaging performed ≤ 3 hours before randomization.
  6. Pre-stroke mRS 0 - 1.
  7. Informed consent form was signed.

Exclusion Criteria:

  1. Evidence of intracranial hemorrhage on CT/MRI, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, or subdural/epidural hemorrhage.
  2. Cerebral midline shift or herniation, or other ventricular mass effect with midline shift as confirmed on CT/MRI.
  3. Bilateral anterior circulation or acute multi-vessel occlusion involving both anterior and posterior circulation, confirmed by CTA or MRA.
  4. Blood pressure >185/110 mmHg and is refractory to medicine.
  5. Known coagulopathy, with international normalized ratio (INR) >1.7 or platelet count <100×10⁹/L;
  6. Current treatment with direct thrombin inhibitors or factor Xa inhibitors;
  7. Patients with severe organ failure (cardiac, pulmonary, renal, or hepatic);
  8. Concomitant malignancy or other conditions with life expectancy under 6 months;
  9. Female who is known to be pregnant;
  10. Prior endovascular attempt for this stroke;;
  11. Currently participation in another clinical study;
  12. Other circumstances that the investigator considers inappropriate for participation.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: EVT group
Verfahren: Patients assigned to the EVT group should undergo EVT as soon as possible, followed by BMM according to the current EVT guidelines.
EVT should be performed as soon as possible in patients randomized to the EVT group. Investigators and clinicians should make every effort to minimize delays related to pre-procedural preparation, with a target interval of no more than 60 minutes from randomization to arterial puncture. EVT in the EVT group can be performed with any thrombectomy device (NMPA approved) usually used at study site.
Aktiver Komparator: Medical group
Arzneimittel: The medical group receives BMM alone. EVT is not performed in the medical group.
The administration of medications is at the treating physician's discretion (for example intravenous fibrinolysis, anticoagulants or antiplatelet) according to current AIS management guidelines but may NOT include any intra-arterial therapies.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
The primary efficacy endpoint is the mRS score at 90 days after randomization.
Zeitfenster: at 90 days after randomization.
at 90 days after randomization.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
mRS score at 180 days after randomization.
Zeitfenster: at 180 days after randomization.
at 180 days after randomization.
Proportion of mRS 0-2 at 90 days and 180 days after randomization.
Zeitfenster: at 90 days and 180 days after randomization.
at 90 days and 180 days after randomization.
Proportion of mRS 0-3 at 90 days and 180 days after randomization.
Zeitfenster: at 90 days and 180 days after randomization.
at 90 days and 180 days after randomization.
Proportion of early neurological improvement
Zeitfenster: at day 7 (±1) or discharge (whichever is earlier).
at day 7 (±1) or discharge (whichever is earlier).
Infarct volume change from baseline NCCT at 7 (±1) days after randomization or discharge (whichever is earlier), or by MRI at 36 (±12) hours.
Zeitfenster: at 7 (±1) days after randomization or discharge (whichever is earlier), or by MRI at 36 (±12) hours.
at 7 (±1) days after randomization or discharge (whichever is earlier), or by MRI at 36 (±12) hours.
EQ-5D-5L score at 90 days.
Zeitfenster: at 90 days.
at 90 days.

Andere Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Incidence of all-cause mortality within 90 days after randomization.
Zeitfenster: within 90 days after randomization.
within 90 days after randomization.
Incidence of symptomatic intracranial hemorrhage (sICH, per Heidelberg Bleeding Classification) at 24±12 hours from onset.
Zeitfenster: at 24±12 hours from onset.
at 24±12 hours from onset.
Incidence of early neurological deterioration
Zeitfenster: defined as a NIHSS increase ≥ 10 points at day 7 (±1) or discharge (whichever is earlier). Death within 7 days of onset is directly judged as neurological deterioration.
defined as a NIHSS increase ≥ 10 points at day 7 (±1) or discharge (whichever is earlier). Death within 7 days of onset is directly judged as neurological deterioration.
Procedure- or device-related complications
Zeitfenster: perioperative period
perioperative period
Serious adverse events (SAE) adjudicated by the Clinical Events Committee.
Zeitfenster: within 180 days after randomization
within 180 days after randomization

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

First Affiliated Hospital of Harbin Medical University

Ermittler

  • Hauptermittler: Huaizhang Shi, MD, PhD, The First Affiliated Hospital of Harbin Medical University, China
  • Hauptermittler: Wei Hu, MD, PhD, The First Affiliated Hospital of USTC (Anhui Provincial Hospital), China
  • Hauptermittler: Jianmin Liu, MD, PhD, Changhai Hospital, China

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

18. September 2026

Primärer Abschluss (Geschätzt)

18. April 2028

Studienabschluss (Geschätzt)

18. April 2028

Studienanmeldedaten

Zuerst eingereicht

25. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. August 2026

Zuerst gepostet (Tatsächlich)

28. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • LARGE CORE-MT

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Data may be shared with bona fide researchers following publication of the main results, upon receipt of a protocol submitted to the LARGE CORE-MT Steering Committee.

IPD-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

  1. The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered.
  2. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials.
  3. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research.
  4. Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection.
  5. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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