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Acute Basilar Artery Occlusion (ABAO), a condition with a high risk of mortality or disability (up to 80%). The safety and efficacy of endovascular thrombectomy (EVT) in ABAO remains uncertain due to inconsistent evidence from random controlled trials (RCTs).
Recent studies have explored the use of MRI in ABAO, this study aims to assess the efficacy and safety of EVT and standard medical therapy (SMT) in the treatment of ABAO within 24 hours of onset. It also aims to explore the feasibility and prognostic value of MRI-based assessment of ABAO infarction using AI image analysis software.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular Thrombectomy | For patients who onset within 4.5 hours and meet the criteria for intravenous thrombolysis treatment, they could receive intravenous thrombolysis treatment beforehand and bridging to endovascular therapy. |
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| Standard Medical Therapy | For patients who onset within 4.5 hours and met the criteria for intravenous thrombolysis treatment, recombinant tissue plasminogen activator (rt-PA) or urokinase, and other intravenous thrombolysis therapies should be pre-administrated. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical Thrombectomy | Device | The endovascular mechanical thrombectomy methods mainly include stent retriever thrombectomy, ADAPT thrombus aspiration technique, or their combination. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of modified Rankin Scale (mRS) score of 0-3 at 90 days | The mRS score range from 0 (no disability) to 6 (death) | 90 days after EVT or SMT |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Death defined as a mRS score of 6 | 90 days after EVT or SMT |
| Rate of mRS score of 0-2 | The mRS score range from 0 (no disability) to 6 (death) |
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Inclusion Criteria:
Exclusion Criteria:
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From January 2020 to September 2022, ABAO patients at Xuanwu Hospital Capital Medical University and 10 branch centers underwent EVT or SMT.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 90 days after EVT or SMT |
| Improvement of mRS score | The mRS score range from 0 (no disability) to 6 (death) The mRS score range from 0 (no disability) to 6 (death) | 90 days after EVT or SMT |
| Change of the National Institutes of Health Stroke Scale (NIHSS) score comparing to baseline | The NIHSS score range from 0 (no deficit) to 42 (maximum deficit). | 24 hours and 5-7 days (or at discharge) after EVT |
| Rate of successful revascularization (mTICI 2b-3) in target blood vessels of EVT group | Immediately after the completion of endovascular therapy. |
| Rate of Intracranial hemorrhage (ICH) | Within 72 hours after EVT or SMT |
| Rate of symptomatic intracranial hemorrhage (sICH) | The sICH was assessed based on the Heidelberg Bleeding Classification, defined as 1) ≥4 points total NIHSS at the time of diagnosis compared to immediately before worsening; 2) ≥2 point in one NIHSS category. The rationale for this is to capture new hemorrhages that produce new neurological symptoms, making them clearly symptomatic but not causing worsening in the original stroke territory; 3) Leading to intubation/hemicraniectomy/EVD placement or other major medical/surgical intervention; 4) Absence of alternative explanation for deterioration. | Within 72 hours after EVT or SMT |
| Rate of non-hemorrhage severe adverse event | ulmonary infection, respiratory failure, heart failure, myocardial infarction, urinary infection, etc. | Within 72 hours after EVT or SMT |
| Surgical instrument-related Complications | Vascular perforation, arterial dissection, arterial embolism, or distal embolism, etc. | Within 72 hours after EVT or SMT |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |