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NCT Number: NCT07090941

EVT in Acute Basilar Artery Occlusion With Large Infarction Core

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.

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Key information

Conditions

Basilar Artery Occlusion Endovascular Treatments Large Core Infarct Large Ischemic Core

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This trial aims to evaluate whether best medical management (BMM) combined with endovascular treatment (EVT) versus BMM alone improves neurological outcomes in acute basilar artery occlusion (BAO) patients with large infarct cores. A centralized 1:1 simple randomization design assigns participants to receive either EVT or BMM based on randomization results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 1. 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).

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 90 (±7) days after procedure

    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.

Secondary outcomes

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

    Time frame: 90 (±7)days after procedure

    The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.

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

    Time frame: 90 (±7) days after procedure

    The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.

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

    Time frame: 24 hours after procedure

    The POST-NIHSS (Posterior National Institutes of Health Stroke Scale) is a tool used to assess the severity of stroke symptoms by evaluating various neurological functions, such as consciousness, vision, movement, and speech. The score helps in gauging the degree of impairment caused by a stroke.

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

    Time frame: Discharge or 5 -7 days after procedure.

    The POST-NIHSS (Posterior National Institutes of Health Stroke Scale) is a tool used to assess the severity of stroke symptoms by evaluating various neurological functions, such as consciousness, vision, movement, and speech. The score helps in gauging the degree of impairment caused by a stroke.

  5. Successful reperfusion postoperatively.

    Time frame: At the end of the operation

    The eTICI (extended Thrombolysis in Cerebral Infarction) score is a standard used to evaluate the degree of reperfusion in acute ischemic stroke patients following endovascular therapy (EVT). It is a further refinement of the mTICI (modified TICI) score.

Other outcomes

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

    Time frame: 90 (±7) days after procedure

    All-cause mortality refers to the rate of death from any cause within a specific time period, without considering the underlying cause of death.

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

    Time frame: Within 48 hours after procedure

    Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 48 hours of endovascular treatment. Intracranial hemorrhage was classified as hemorrhagic infarction or parenchymal hematoma. The sICH was defined as ICH associated with a worsening of 4 or more points on the NIHSS or resulting in death and cerebral herniation, which were not present at baseline.

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

    Time frame: within 48 hours after procedure

    Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 48 hours of endovascular treatment. Intracranial hemorrhage was classified as hemorrhagic infarction or parenchymal hematoma.

Study contacts

Contact information is provided by the study sponsor or research team.

Wen Sun, PhD

CONTACT

[email protected]

8615050589620

Zhengqiang Zhao, PhD

CONTACT

[email protected]

8613976015677

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Hainan Medical University

Other Gov

Registry information

Official study title

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

Acronym: BOLT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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