Trial of Endovascular Treatment in Acute Basilar Artery Occlusion Patients With a Large Infarct Core

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the efficacy and safety of best medical management (BMM) combined with endovascular treatment (EVT) versus BMM alone in acute basilar artery occlusion (BAO) patients with large infarct cores.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. Age ≥18 years. 2. Symptoms and signs consistent with basilar artery ischemia. 3. Basilar artery or vertebral artery occlusion confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), digital subtraction angiography (DSA); if vertebral artery occlusion is present, it must completely obstruct blood flow to the basilar artery.

• 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.

Locations
Other Locations
China
First Affiliated Hospital of Hainan Medical University
RECRUITING
Haikou
Contact Information
Primary
Zhengqiang Zhao, PhD
zhenqiang.zhao@qq.com
8613976015677
Backup
Wen Sun, PhD
sunwen_medneuro@163.com
8615050589620
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 348
Treatments
Experimental: 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.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Hainan Medical University

This content was sourced from clinicaltrials.gov

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