EVT in Acute Basilar Artery Occlusion With Large Infarction Core

NCT07090941 | Recruiting DMC

• 1 other identifier: BOLT
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Basilar Artery Occlusion; Large Ischemic Core; Large Core Infarct; Endovascular Treatments

Keywords

Basilar Artery Occlusion; Endovascular treatment; Large infarct core

Outcome Measures

Primary Outcomes (1)

• Shift analysis of the improvement trend in modified Rankin Scale (mRS) scores at 90 (±7) days after randomization.

  Shift analysis is a statistical method used to evaluate the overall distribution change in modified Rankin Scale (mRS) scores, assessing whether an intervention leads to a general shift toward better outcomes across all score categories.

  90 (±7) days after procedure

Secondary Outcomes (5)

• Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 (±7) days after randomization.

  90 (±7)days after procedure

• Proportion of patients with a modified Rankin Scale (mRS) score of 0-2 at 90 (±7) days after randomization.

  90 (±7) days after procedure

• Change in POST-NIHSS score from baseline at 24 hours postoperatively.

  24 hours after procedure

• Change in POST-NIHSS score from baseline at discharge or 5-7 days postoperatively.

  Discharge or 5 -7 days after procedure.

• Successful reperfusion postoperatively.

  At the end of the operation

Other Outcomes (3)

• All-cause mortality at 90 (±7) days after randomization.

  90 (±7) days after procedure

• Incidence of symptomatic intracerebral hemorrhage (sICH) within 48 hours after randomization (Heidelberg bleeding classification).

  Within 48 hours after procedure

• Incidence of any intracerebral hemorrhage within 48 hours after randomization (Heidelberg bleeding classification).

  within 48 hours after procedure

Study Arms (2)

Endovascular Treatment Group

EXPERIMENTAL

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.

Procedure: Endovascular Treatment

Best Medical Management Group

NO INTERVENTION

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.

Interventions

Endovascular Treatment PROCEDURE

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.

Endovascular Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. POST-NIHSS score ≥10 at randomization. 5. Time from symptom onset to randomization ≤24 hours (symptom onset defined as last known well time).
• \. pc-ASPECTS of 3-5 on CT/MRI (for patients aged \<80 years) or pc-ASPECTS of 3-7 (for patients aged ≥80 years).
• \. Willingness of the patient or legally authorized representative to comply with protocol requirements and data collection procedures, with documented informed consent.

You may not qualify if:

• \. Pre-stroke modified Rankin Scale (mRS) score \>2. 2. Factors in the target vessel that are expected to prevent completion of endovascular treatment.
• \. Concurrent anterior and posterior circulation strokes or multivessel occlusions.
• \. Significant mass effect with imaging or clinical signs of obstructive hydrocephalus or tonsillar herniation.
• \. Basilar artery occlusion confirmed as chronic by prior imaging or investigator judgment.
• \. Presence of untreated intracranial aneurysms, intracranial tumors (except small meningiomas), or intracranial vascular malformations.
• \. Intracranial hemorrhage within the past 6 months, including parenchymal brain hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage.
• \. Presence of active bleeding, coagulation disorders, or uncorrectable bleeding tendencies.
• \. Severe heart, liver, or kidney dysfunction or other severe systemic late-stage diseases.
• \. 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).
• \. 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).

Sponsors & Collaborators

• The First Affiliated Hospital of Hainan Medical University: lead

Study Sites (1)

First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570100, China

RECRUITING

Central Study Contacts

Zhengqiang Zhao, PhD

CONTACT

8613976015677; zhenqiang.zhao@qq.com

Wen Sun, PhD

CONTACT

8615050589620; sunwen_medneuro@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 29, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)