EVT in Acute Basilar Artery Occlusion With Large Infarction Core

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Hainan Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

1. Pre-stroke modified Rankin Scale (mRS) score >2. 2. Factors in the target vessel that are expected to prevent completion of endovascular treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endovascular Treatment

    Procedure/Surgery

    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.

Treatment groups

372 Participants
are divided into 2 treatment groups
Group A: Endovascular Treatment GroupExperimental treatment 1 intervention
Group B: Best Medical Management GroupNo intervention 0 interventions

Trial outcomes

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.

Time frame
90 (±7) days after randomization

Secondary outcomes

1

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

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

Time frame
90 (±7)days after randomization
2

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

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

Time frame
90 (±7) days after randomization
3

Change in Posterior National Institutes of Health Stroke Scale (POST-NIHSS) from baseline at 24 hours after randomization

The Posterior National Institutes of Health Stroke Scale (POST-NIHSS) is a tool used to assess the severity of stroke symptoms by evaluating various neurological functions, such as consciousness, vision, movement, and speech. The POST-NIHSS ranges from 0 to 52, with higher scores indicating more severe neurological deficits and a worse clinical condition.The score helps in gauging the degree of impairment caused by a stroke.

Time frame
24 hours after randomization
4

Change in Posterior National Institutes of Health Stroke Scale (POST-NIHSS) from baseline at discharge or 7±1 days after randomization.

The Posterior National Institutes of Health Stroke Scale (POST-NIHSS) is a tool used to assess the severity of stroke symptoms by evaluating various neurological functions, such as consciousness, vision, movement, and speech. The POST-NIHSS ranges from 0 to 52, with higher scores indicating more severe neurological deficits and a worse clinical condition.The score helps in gauging the degree of impairment caused by a stroke.

Time frame
Discharge or 7±1 days after randomization

Other outcomes

1

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

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

Time frame
90 (±7) days after randomization
2

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

Intracranial hemorrhage (ICH) was assessed with the Heidelberg Bleeding Classification within 48 hours after randomization. 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.

Time frame
Within 48 hours after randomization
3

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

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

Time frame
within 48 hours after randomization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Hainan Medical University

Lead sponsor

Heyuan people's Hospital

Collaborator

Wuhan No.1 Hospital

Collaborator

People's Hospital of Lixin Country

Collaborator

The Eighth Affiliated Hospital of Southern Medical University

Collaborator

Longyan City First Hospital

Collaborator

People's Hospital of Guoyang County

Collaborator

Maoming Hospital of Traditional Chinese Medicine

Collaborator

The Central Hospital of Xiangtan

Collaborator

The Fourth Hospital of Liuan

Collaborator

Wuwei City People's Hospital

Collaborator

Dongguan People's Hospital

Collaborator

Jingmen Central Hospital

Collaborator

THE SECOND PEOPLE'S HOSPITAL, WUHU

Collaborator

Zhongshan Hospital Of Traditional Chinese Medicine

Collaborator

The First Hospital of Putian City

Collaborator

Yijishan Hospital

Collaborator

Liaocheng People's Hospital

Collaborator

People's Hospital of Dongxihu District

Collaborator

First People's Hospital of Yulin

Collaborator

Wuhan Central Hospital

Collaborator

Tongliao People's Hospital

Collaborator

Huaibei Miner General Hospital, Huaibei, China.

Collaborator

The First People's Hospital of Zhangjiagang

Collaborator

Guangdong Second Provincial General Hospital

Collaborator

The affiliated Changsha Hospital of Xiangya School of Medicine, Central South University

Collaborator

Wangjiang People's Hospital of Anhui Province

Collaborator

The Third Affiliated Hospital of Guangzhou Medical University

Collaborator

The First Affiliated Hospital of Nanchang University

Collaborator

Maanshan People's Hospital

Collaborator

People's Hospital of Yingshang County

Collaborator

Haiyan People's Hospital

Collaborator

The First Affiliated Hospital of the University of Science and Technology of China

Collaborator