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Endovascular Therapy for Acute Basilar Artery Occlusion With Large Ischemic Core

30 juni 2026 bijgewerkt door: The First Affiliated Hospital of University of Science and Technology of China

Efficacy and Safety of Endovascular Therapy for Acute Basilar Artery Occlusion With Large Ischemic Core: A Prospective, Multicenter, Randomized Controlled Trial

Acute basilar artery occlusion is associated with high mortality and severe disability. Previous randomized trials have demonstrated the benefit of endovascular therapy in selected patients with basilar artery occlusion; however, patients with large ischemic core, commonly defined by low posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS), remain underrepresented and the benefit-risk profile of endovascular therapy in this subgroup is uncertain.

This prospective, multicenter, randomized, open-label, blinded-endpoint trial will evaluate the efficacy and safety of endovascular therapy plus best medical management compared with best medical management alone in patients with acute basilar artery occlusion within 24 hours from symptom onset or last known well and pc-ASPECTS <7. Eligible participants will be randomized in a 1:1 ratio to receive endovascular therapy plus best medical management or best medical management alone. The primary outcome is favorable functional outcome, defined as a modified Rankin Scale score of 0 to 3 at 90 days.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is a prospective, multicenter, randomized, open-label, parallel-group, blinded-endpoint clinical trial. Patients aged 18 to 80 years with acute posterior circulation ischemic stroke, angiographically confirmed basilar artery occlusion, pc-ASPECTS <7 on CT/CTA source images or MRI-DWI, baseline NIHSS score ≥6, and randomization within 24 hours from symptom onset or last known well will be enrolled.

Participants will be randomly assigned in a 1:1 ratio to either endovascular therapy plus best medical management or best medical management alone. Randomization will be performed using a centralized randomization system with stratified permuted blocks. Stratification factors include study center, baseline NIHSS severity category, and onset-to-randomization time window.

Patients in both groups may receive standard intravenous thrombolysis if eligible according to current guidelines. Endovascular therapy may include stent retriever thrombectomy, direct aspiration thrombectomy, or combined techniques, at the discretion of the treating neurointerventionalist.

The primary efficacy endpoint is the proportion of patients achieving a modified Rankin Scale score of 0 to 3 at 90 days. Secondary endpoints include modified Rankin Scale score of 0 to 2 at 90 days, ordinal shift analysis of the modified Rankin Scale, changes in NIHSS and GCS scores, imaging outcomes, quality of life assessed by EQ-5D, and Barthel Index at 90 days. Safety outcomes include symptomatic intracranial hemorrhage, any intracranial hemorrhage, mortality, procedure-related complications, and serious adverse events.

Studietype

Ingrijpend

Inschrijving (Geschat)

256

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Clinical symptoms or imaging findings suggestive of acute posterior circulation ischemic stroke.
  • Basilar artery occlusion confirmed by CTA, MRA, or DSA.
  • Posterior circulation ASPECTS <7 on CT, CTA source images, or MRI-DWI.
  • Age 18 to 80 years.
  • Time from symptom onset or last known well to randomization within 24 hours.
  • Written informed consent obtained from the patient or legally authorized representative.
  • Baseline NIHSS score ≥6 before randomization.

Exclusion Criteria:

  • Pre-stroke modified Rankin Scale score ≥3.
  • Pregnancy or lactation.
  • Known allergy to contrast agents or nickel-titanium alloy.
  • Current participation in another clinical trial.
  • Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg that cannot be controlled with antihypertensive therapy.
  • Known hereditary or acquired bleeding diathesis, coagulation factor deficiency, or current oral anticoagulant use with INR >1.7.
  • Blood glucose <50 mg/dL or >400 mg/dL, platelet count <50 × 10^9/L, or hematocrit <25%.
  • Life expectancy less than 1 year.
  • Inability to complete 90-day follow-up.
  • Definite history of cerebral vasculitis.
  • Pre-existing neurological or psychiatric disorder that may interfere with neurological or functional assessment.
  • Intracranial hemorrhage on CT or MRI, except for cerebral microbleeds <5 mm on MRI.
  • Vascular tortuosity, anatomical variation, or arterial dissection on CTA, MRA, or DSA that precludes endovascular treatment.
  • Intracranial tumor, except for small meningioma.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Endovascular Therapy Plus Best Medical Management
Participants assigned to this group will receive endovascular therapy in addition to best medical management. Endovascular therapy may include stent retriever thrombectomy, direct aspiration thrombectomy, or combined techniques, according to the vascular anatomy, thrombus characteristics, and operator judgment. Eligible patients may receive intravenous thrombolysis before endovascular therapy according to standard clinical guidelines.
Procedure: Endovascular Therapy
Endovascular therapy consists of mechanical thrombectomy using stent retriever, direct aspiration, or combined techniques with the goal of achieving rapid and effective reperfusion of the occluded basilar artery.
Andere namen:
  • Mechanische trombectomie
Actieve vergelijker: Best Medical Management Alone
Participants assigned to this group will receive best medical management according to current stroke guidelines. Eligible patients within the intravenous thrombolysis time window may receive standard-dose intravenous thrombolysis. Other medical treatment may include antithrombotic therapy, risk factor management, blood pressure management, and supportive stroke care according to local and guideline-based practice.
Ander: Best Medical Management
Best medical management includes intravenous thrombolysis when eligible, antithrombotic therapy, standard stroke unit care, management of vascular risk factors, blood pressure control, and supportive care according to current clinical guidelines.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Favorable Functional Outcome at 90 Days
Tijdsspanne: 90 days after randomization
Proportion of participants with a modified Rankin Scale score of 0 to 3 at 90 days. The modified Rankin Scale ranges from 0 to 6, with 0 indicating no symptoms, 5 indicating severe disability, and 6 indicating death.
90 days after randomization

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Excellent Functional Outcome at 90 Days
Tijdsspanne: 90 days after randomization
Proportion of participants with a modified Rankin Scale score of 0 to 2 at 90 days.
90 days after randomization
Successful Recanalization on CTA/MRA
Tijdsspanne: Within 72 hours
Proportion of participants with successful vascular recanalization on follow-up CTA or MRA.
Within 72 hours
Ordinal Shift in Modified Rankin Scale Score
Tijdsspanne: 90 days after randomization
Distribution of modified Rankin Scale scores at 90 days analyzed across all ordinal categories.
90 days after randomization
Symptomatic Intracranial Hemorrhage
Tijdsspanne: Within 36 hours after randomization
Occurrence of symptomatic intracranial hemorrhage after randomization according to the prespecified trial definition.
Within 36 hours after randomization
All-cause Mortality
Tijdsspanne: 90 days
Death from any cause.
90 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The First Affiliated Hospital of University of Science and Technology of China

Medewerkers

Linyi People's Hospital
Dalian Municipal Central Hospital
Shanghai Minhang District Central Hospital
Fujian Zhangzhou hospital

Onderzoekers

  • Hoofdonderzoeker: Wei Hu, PhD, The First Affiliated Hospital of University of Science and Technology of China

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

30 juli 2029

Studie voltooiing (Geschat)

31 december 2029

Studieregistratiedata

Eerst ingediend

23 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2026

Eerst geplaatst (Werkelijk)

29 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

30 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • USTC-BAO-LARGE-2025KY851

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

ndividual participant data will not be publicly shared due to restrictions related to patient privacy, ethics approval, institutional policies, and informed consent. Reasonable requests for de-identified data may be considered after publication of the primary results, subject to approval by the principal investigator and relevant ethics committees.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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