Acute Ischemic Stroke, Basilar Artery Occlusion, Large Ischemic Core
Conditions
Keywords
Basilar artery occlusion, Endovascular therapy, Mechanical thrombectomy, Posterior circulation stroke, Large ischemic core
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEndovascular 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.
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.
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Dalian Municipal Central Hospital
Linyi People's Hospital
Fujian Zhangzhou hospital
Shanghai Minhang District Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the nature of endovascular therapy, treating physicians and participants will not be masked to treatment assignment. Outcome assessors for the 90-day modified Rankin Scale and the independent imaging core laboratory will be blinded to treatment assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Favorable Functional Outcome at 90 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Excellent Functional Outcome at 90 Days | 90 days after randomization | Proportion of participants with a modified Rankin Scale score of 0 to 2 at 90 days. |
| Successful Recanalization on CTA/MRA | Within 72 hours | Proportion of participants with successful vascular recanalization on follow-up CTA or MRA. |
| Ordinal Shift in Modified Rankin Scale Score | 90 days after randomization | Distribution of modified Rankin Scale scores at 90 days analyzed across all ordinal categories. |
| Symptomatic Intracranial Hemorrhage | Within 36 hours after randomization | Occurrence of symptomatic intracranial hemorrhage after randomization according to the prespecified trial definition. |
| All-cause Mortality | 90 days | Death from any cause. |
Contacts
CONTACTChunrong Tao, PhD
PRINCIPAL_INVESTIGATORWei Hu, PhD
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed