EVT in Acute Basilar Artery Occlusion With Large Infarction Core
NCT ID: NCT07090941
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
348 participants
INTERVENTIONAL
2025-08-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Endovascular Treatment Group
Endovascular treatment procedures will be performed in accordance with each center's standard operating protocols. Based on the characteristics of vascular lesions and clinical judgment, investigators may select appropriate interventions for stenosis or occlusion, including stent retriever thrombectomy, aspiration thrombectomy, balloon angioplasty, stenting, intra-arterial thrombolysis, or various combinations of these methods.
Endovascular Treatment
The vascular access route is selected based on the patient's anatomical characteristics and operator discretion. Endovascular treatment (EVT) procedures must adhere to each participating center's standardized operating protocols. Upon confirmation of vascular occlusion, EVT may be performed using devices approved by China's National Medical Products Administration (NMPA). Based on lesion-specific features and operator judgment, permissible techniques include stent retriever thrombectomy, aspiration thrombectomy, balloon angioplasty with or without stenting, or intra-arterial thrombolysis. Investigational devices are strictly prohibited.
Best Medical Management Group
Participants receive the best medical management only. Best Medical Treatment and maximum supportive care according to local guidelines, not including mechanical thrombectomy or intra-arterial treatment.
No interventions assigned to this group
Interventions
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Endovascular Treatment
The vascular access route is selected based on the patient's anatomical characteristics and operator discretion. Endovascular treatment (EVT) procedures must adhere to each participating center's standardized operating protocols. Upon confirmation of vascular occlusion, EVT may be performed using devices approved by China's National Medical Products Administration (NMPA). Based on lesion-specific features and operator judgment, permissible techniques include stent retriever thrombectomy, aspiration thrombectomy, balloon angioplasty with or without stenting, or intra-arterial thrombolysis. Investigational devices are strictly prohibited.
Eligibility Criteria
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Inclusion Criteria
4\. POST-NIHSS score ≥10 at randomization. 5. Time from symptom onset to randomization ≤24 hours (symptom onset defined as last known well time).
6\. pc-ASPECTS of 3-5 on CT/MRI (for patients aged \<80 years) or pc-ASPECTS of 3-7 (for patients aged ≥80 years).
7\. Willingness of the patient or legally authorized representative to comply with protocol requirements and data collection procedures, with documented informed consent.
Exclusion Criteria
3\. Concurrent anterior and posterior circulation strokes or multivessel occlusions.
4\. Significant mass effect with imaging or clinical signs of obstructive hydrocephalus or tonsillar herniation.
5\. Basilar artery occlusion confirmed as chronic by prior imaging or investigator judgment.
6\. Presence of untreated intracranial aneurysms, intracranial tumors (except small meningiomas), or intracranial vascular malformations.
7\. Intracranial hemorrhage within the past 6 months, including parenchymal brain hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage.
8\. Presence of active bleeding, coagulation disorders, or uncorrectable bleeding tendencies.
9\. Severe heart, liver, or kidney dysfunction or other severe systemic late-stage diseases.
10\. Known allergy to iodine contrast agents or other treatment-related drugs. 11. Medically uncontrolled refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) (Note: Participants can be included if their blood pressure is controllable with medication and maintained at an acceptable level).
12\. Uncontrollable blood glucose \<2.8 mmol/L or \>22.2 mmol/L. 13. Pregnancy or breastfeeding. 14. Life expectancy \<6 months. 15. Participation in other clinical studies that may affect outcome assessment. 16. Investigator's judgment that the patient is unsuitable for participation in this study or may face significant risks (e.g., due to mental illness, cognitive, or emotional disorders preventing understanding and/or compliance with study procedures and/or follow-up).
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Hainan Medical University
OTHER_GOV
Responsible Party
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zhaozhenqiang
Principal Investigator
Locations
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First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BOLT
Identifier Type: -
Identifier Source: org_study_id
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