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The purpose of this study is to evaluate whether endovascular thrombectomy (EVT) combined with best medical management (BMM) leads to better functional outcomes than BMM alone in patients with acute basilar artery occlusion with posterior circulation large infarct.
This study is a multicenter, prospective, cohort study that prospectively enrolled consecutive patients with acute basilar artery occlusion and large core infarction in the posterior circulation, confirmed by imaging (CTA/MRA/DSA). Written informed consent was obtained from all participants or their legal representatives prior to enrollment. Patients were divided into the best medical management (BMM) group and the endovascular thrombectomy (EVT) group according to the treatment they received. This study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular Thrombectomy (EVT) | The EVT group would include the following interventions: stent-retriever thrombectomy, aspiration thrombectomy, balloon angioplasty and/or stenting, intra-arterial medication administration, or a combination of these approaches. |
| |
| Best Medical Management (BMM) | BMM was tailored according to institutional guidelines and included intravenous thrombolysis (IVT), antiplatelet therapy, anticoagulation, or multimodal combinations. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Thrombectomy (EVT) | Procedure | A maximum of six attempts to retrieve the thrombus in a single vessel can be made with any Solitaire AB/FR device or aspiration. In case an atherosclerotic lesion is found underlying the occlusive lesion, angioplasty and subsequent stenting through detachment of the Solitaire device will be allowed |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of modified Rankin scale 0-3 at 90 (±14) days after enrollment | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal Shift analysis of mRS score at 90 (±14) days after enrollment | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality within 90 (±14) days | all-cause mortality | 90 (±14) days |
| Rate of Symptomatic intracranial hemorrhage (SICH) | Symptomatic intracranial hemorrhage (SICH) within 24-72 hours after enrollment |
Inclusion Criteria:
Exclusion Criteria:
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Acute basilar artery occlusion with large infarct
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| Name | Affiliation | Role |
|---|---|---|
| gao feng, professor | Beijing Tiantan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | 100070 | China |
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| Rate of mRS 0-2 at 90 (±14) days after enrollment | 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 |
| Rate of Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after enrollment | EuroQol Five Dimensions (EQ-5D) 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 |
| 24-72 hours |