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This study assesses the efficacy and safety of endovascular treatment for acute mild basilar artery occlusion within a multicenter, prospective, open-label, endpoint-blinded, randomized controlled clinical trial.
This is a multicenter, prospective, randomized, open-label, controlled trial with blinded outcome assessment (PROBE design) evaluating endovascular therapy (EVT) for patients with acute mild basilar artery occlusion (MBAO). Acute MBAO is defined as basilar artery occlusion confirmed by CTA/MRA/DSA, with mild neurological deficits (baseline NIHSS ≥2 and <10). Participants will be randomized in a 1:1 ratio to receive either EVT plus best medical therapy or best medical therapy alone. The primary outcome is the rate of good functional status at 90 days after randomization was defined as the modified Rankin Scale (mRS) score of 0-2 at 90 days. Secondary outcomes include the distribution of mRS scores at 90 days, 90-day all-cause mortality, and the incidence of symptomatic intracranial hemorrhage (sICH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular Treatment Group | Experimental | Participants randomized to the endovascular recanalization arm will receive endovascular treatment in addition to best medical management. The procedure aims to achieve recanalization of the occluded basilar artery using mechanical thrombectomy techniques, including stent retriever and/or aspiration-based approaches. When necessary, adjunctive endovascular measures may be performed as rescue therapy at the discretion of the treating neurointerventionalist. |
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| Best Medical Management Group | Experimental | Participants randomized to this arm will receive best medical management alone, consistent with current guideline recommendations for the acute and secondary prevention phases of ischemic stroke. No endovascular recanalization procedures are permitted after randomization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Recanalization Strategy | Procedure | The endovascular approach is selected by the treating neurointerventionalist based on angiographic findings, occlusion characteristics, and procedural feasibility. Permitted techniques include mechanical thrombectomy using stent retriever and/or aspiration-based methods. Adjunctive endovascular procedures, such as balloon angioplasty, stent placement, or intra-arterial thrombolysis, may be used when deemed necessary to achieve or maintain vessel patency. Angiographic reperfusion is assessed during the procedure, and treatment is terminated once adequate revascularization is obtained. Subsequent medical management is individualized according to stroke mechanism, procedural findings, and post-treatment imaging. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate modified Rankin Scale (mRS) score 0-2 at 90 days | The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death. | 90±14 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| mRS score as an ordinal scale at 90 days after randomization | The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death. | 90±14 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate within 90 days after randomization | All cause of mortality within 90 days after randomization. | 90±14 days after randomization |
| Rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification within 24 hours of randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Gao, MD | Contact | 13581936066 | gaofengletter@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Gao | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100070 | China |
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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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| Best Medical Management | Drug | Best medical management consists of comprehensive evidence-based medical therapy for acute ischemic stroke, encompassing acute supportive care, neurological and physiological monitoring, etiological evaluation, and secondary prevention strategies. Standard pharmacological treatments are administered as appropriate, together with risk factor modification and supportive care measures, in accordance with current guideline recommendations. Endovascular recanalization procedures are not included in this treatment strategy. |
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| The rate of 0-1 and 0-3 mRS scores after randomization for 90 days | The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death. | 90±14 days after randomization |
| National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization | National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits. | 24 (-6/+12) hours after randomization |
| NIHSS score at 7 days after randomization or discharge (whichever occurs first), as well as changes from baseline | NIHSS score at 7 days after randomization or discharge (whichever came first) The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits. | 7 days after randomization or at discharge |
| European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score 90 days after randomization | EuroQol Five Dimensions (EQ-5D-5L) is a standardized instrument for measuring the general health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5. | 90±14 days after randomization |
| Barthel index 95-100 points 90 days after randomization | The proportion of Barthel Index 95-100 at 90 days after randomization. | 90±14 days after randomization |
| The recanalization of the basilar artery 24 hours after randomization (confirmed by CTA, MRA, DSA, or TCD) | Basilar artery recanalization at 24 hours after randomization (confirmed by CTA, MRA, DSA or TCD). | 24 (-6/+12) hours after randomization |
| The technical success rate is defined as the successful recanalization of the target vessel at the end of the surgery (Extended Thrombolysis Classification for Cerebral Infarction [eTICI] 2b-3) | Technical success rate, defined as successful recanalization of target vessels at the end of surgery (The expanded Thrombolysis in Cerebral Infarction (eTICI) scale eTICI 2b-3). | At the end of the operation |
Heidelberg standard was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below: 4 points total NIHSS at the time of diagnosis compared to immediately before worsening. 2 point in one NIHSS category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention. Absence of alternative explanation for deterioration. |
| 24 (-6/+12) hours after randomization |
| Rate of any intracranial hemorrhage identified by CT or MRI imaging within 24 hours after randomization | Any intracranial hemorrhage identified by CT or MRI imaging within 24 hours. | 24 hours after randomization |
| All cause of mortality within 7 days after randomization | All cause of mortality within 7 days after randomization. | 7 days after randomization or at discharge |
| Surgical related complications: arterial perforation, arterial dissection, and embolism in newly developed vascular areas | Surgical related complications: arterial perforation, arterial dissection, and embolism in newly developed vascular areas. | At the end of the operation or intraoperative |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |