Endovascular Therapy for Acute Basilar Artery Occlusion With Large Ischemic Core
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Chunrong Tao, PhD
- Telefonní číslo: +8662284079
- E-mail: chunrongtao@126.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
Ostatní jména:
|
|
Aktivní komparátor: 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.
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Favorable Functional Outcome at 90 Days
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Excellent Functional Outcome at 90 Days
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 90 days
|
Death from any cause.
|
90 days
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Wei Hu, PhD, The First Affiliated Hospital of University of Science and Technology of China
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- USTC-BAO-LARGE-2025KY851
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .