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To assess the effect of endovascular thrombectomy alone compared to intravenous thrombolysis plus endovascular thrombectomy in acute basilar artery occlusion patients within 4.5 hours from onset on efficacy and safety outcomes.
Two recent randomized, controlled trials from China-ATTENTION (Trial of Endovascular Treatment of Acute Basilar-Artery Occlusion) and BAOCHE (Trial of Thrombectomy 6 to 24 Hours after Stroke Due to Basilar-Artery Occlusion) have shown a significantly beneficial effect of endovascular thrombectomy in patients with an acute symptomatic basilar artery occlusion. The DEVT (Direct Endovascular Treatment versus Standard Bridging Therapy for Acute Stroke Patients with Large Vessel Occlusion in The Anterior Circulation) and DIRECT-MT (Direct Intraarterial Thrombectomy in Order to Revascularize Acute Ischemic Stroke Patients with Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals Trial) trials showed that endovascular thrombectomy alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional independence for stroke patients with large vessel occlusion. However, it is unclear whether endovascular thrombectomy alone is noninferior to intravenous thrombolysis bridging with endovascular thrombectomy for achieving functional independence at 90 days among patients with acute basilar artery occlusion. Therefore, additional studies are needed to explore the potential benefit of endovascular thrombectomy alone in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular thrombectomy alone | Experimental | Patients will receive endovascular thrombectomy without intravenous thrombolysis. |
|
| Intravenous thrombolysis plus endovascular thrombectomy | Active Comparator | Patients will receive intravenous alteplase (0.9mg/kg, maximum 90mg) or tenecteplase (0.25mg/kg, maximum 25mg) before endovascular thrombectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous thrombolysis | Drug | Patients will receive intravenous alteplase (0.9mg/kg, maximum 90mg) or tenecteplase (0.25mg/kg, maximum 25mg) before endovascular thrombectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with modified Rankin Score 0-2 at day 90 (±14 days) | The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability. | 90 (± 14 days) after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with modified Rankin Score 0-3 at day 90 (±14 days) | The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability. | 90 (± 14 days) after procedure |
| Proportion of patients with modified Rankin Score 0-1 at day 90 (±14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic intracerebral hemorrhage (sICH) within 72 hours | Symptomatic intracranial hemorrhage defined as local or remote parenchymal hemorrhage type 2, subarachnoid hemorrhage, or intraventricular hemorrhage that led to death or was observed on an imaging scan obtained 24 to 72 hours after treatment, combined with a neurologic worsening of at least 4 points from baseline on the NIHSS or from the lowest NIHSS score between baseline and 24 hours, or death from any cause within 90 days. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Hu, MD | Contact | +8615155510611 | andinghu@ustc.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wei Hu, MD | The First Affiliated Hospital of University of Science and Technology of China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Recruiting | Hefei | Anhui | 230001 | China |
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|
| Endovascular thrombectomy | Procedure | Endovascular thrombectomy |
|
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability. |
| 90 (± 14 days) after procedure |
| Proportion of patients with modified Rankin Score 0-4 at day 90 (±14 days) | The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability. | 90 (± 14 days) after procedure |
| Ordinal Shift analysis of modified Rankin Score at day 90 (±14 days) | The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability. | 90 (± 14 days) after procedure |
| Score on the National Institute of Health Stroke Scale (NIHSS) at 24 hours | The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit. | 24 hours after procedure |
| Score on the NIHSS at 5-7 days or discharge | The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit. | 5-7 days or discharge after procedure |
| Score on the EuroQoL 5-dimensions 5-level (EQ5D-5L) at 90 days (±14 days) | The EQ-5D-5L is a questionnaire designed to assess five dimensions of life quality related to mobility, self-care, usual activities, pain or discomfort, and anxiety or depression (range: 0.39 to 1, with a higher score indicating a higher quality of living) | 90 (± 14 days) after procedure |
| level of activities of daily living (Barthel index, BI) at 90 days (±14 days) | The Barthel Index is an ordinal scale for measuring performance of patients'self-care activities of daily living. Scores range from 0 to 100, with 0 indicating severe disability and 95 or 100 indicating no disability that interferes with daily activities. | 90 (± 14 days) after procedure |
| Successful reperfusion (Extended thrombolysis in cerebral infarction [eTICI] score 2b50-3) on digital substraction angiography (DSA) prior to thrombectomy | Evaluate effect of intravenous thrombolysis on reperfusion | within 5 minutes at angiography |
| Successful reperfusion on final angiography of thrombectomy | Evaluate effect of thrombectomy on reperfusion | Within 5 minutes at final angiography of thrombectomy |
| Successful recanalization on CT or MR angiography within 72 hours | Evaluate vascular patency after treatment | Within 72 hours after procedure |
| Infarct volume (Posterior Circulation Acute Stroke Prognosis Early Computed Tomography Score, PC-ASPECTS) evaluated on CT or MRI within 72 hours | PC-ASPECTS=10 indicates a normal scan, PC-ASPECTS=0 indicates early ischemic changes or hypoattenuation in all above territories. 1 or 2 points each are subtracted for early ischemic changes or hypoattenuation in: left or right thalamus, cerebellum or posterior cerebral artery territory, respectively (1 point); any part of midbrain or pons (2 points) | Within 72 hours after procedure |
| Within 72 hours after procedure |
| Any intracerebral hemorrhage within 72 hours | Evaluate intracerebral hemorrhage | Within 72 hours after procedure |
| Overall mortality at 7 (± 2 days) and 90 (± 14 days) | Evaluate death rate | 7 (± 2 days) and 90 (± 14 days) after procedure |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D000077785 | Tenecteplase |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
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