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 volunteersQualifiers
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/SurgeryThe 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
348 Participants
are divided into 2 treatment groupsGroup 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 procedureSecondary 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 procedure2
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 procedure3
Change in POST-NIHSS score from baseline at 24 hours postoperatively.
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.
Time frame
24 hours after procedure4
Change in POST-NIHSS score from baseline at discharge or 5-7 days postoperatively.
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.
Time frame
Discharge or 5 -7 days after procedure.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 procedure2
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 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.
Time frame
Within 48 hours after procedure3
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 of endovascular treatment. Intracranial hemorrhage was classified as hemorrhagic infarction or parenchymal hematoma.
Time frame
within 48 hours after procedureSponsors and contacts
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Source ClinicalTrials.gov