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| Name | Class |
|---|---|
| Dalian Municipal Central Hospital | OTHER |
| Linyi People's Hospital | OTHER |
| Fujian Zhangzhou hospital | UNKNOWN |
| Shanghai Minhang District Central Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular Therapy Plus Best Medical Management | Experimental | 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. |
|
| Best Medical Management Alone | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Therapy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Favorable Functional Outcome at 90 Days | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Excellent Functional Outcome at 90 Days | 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 | Proportion of participants with successful vascular recanalization on follow-up CTA or MRA. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunrong Tao, PhD | Contact | +8662284079 | chunrongtao@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Hu, PhD | The First Affiliated Hospital of University of Science and Technology of China | Principal Investigator |
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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.
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| UNKNOWN |
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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.
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| Best Medical Management | Other | 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. |
|
| Within 72 hours |
| Ordinal Shift in Modified Rankin Scale Score | Distribution of modified Rankin Scale scores at 90 days analyzed across all ordinal categories. | 90 days after randomization |
| Symptomatic Intracranial Hemorrhage | Occurrence of symptomatic intracranial hemorrhage after randomization according to the prespecified trial definition. | Within 36 hours after randomization |
| All-cause Mortality | Death from any cause. | 90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |