The Efficacy and Safety of Endovascular Treatment for Acute Mild Basilar Artery Occlusion

Official title

The Efficacy and Safety of Endovascular Treatment for Acute Mild Basilar Artery Occlusion: A Multicenter, Prospective, Open-Label, Endpoint-Blinded, Randomized Controlled Clinical Trial

Overview

This study assesses the efficacy and safety of endovascular treatment for acute mild basilar artery occlusion within a multicenter, prospective, open-label, endpoint-blinded, randomized controlled clinical trial.

Detailed description

This is a multicenter, prospective, randomized, open-label, controlled trial with blinded outcome assessment (PROBE design) evaluating endovascular therapy (EVT) for patients with acute mild basilar artery occlusion (MBAO). Acute MBAO is defined as basilar artery occlusion confirmed by CTA/MRA/DSA, with mild neurological deficits (baseline NIHSS ≥2 and \<10). Participants will be randomized in a 1:1 ratio to receive either EVT plus best medical therapy or best medical therapy alone. The primary outcome is the rate of good functional status at 90 days after randomization was defined as the modified Rankin Scale (mRS) score of 0-2 at 90 days. Secondary outcomes include the distribution of mRS scores at 90 days, 90-day all-cause mortality, and the incidence of symptomatic intracranial hemorrhage (sICH).

Interventions

• Procedure Endovascular Recanalization Strategy
  The endovascular approach is selected by the treating neurointerventionalist based on angiographic findings, occlusion characteristics, and procedural feasibility. Permitted techniques include mechanical thrombectomy using stent retriever and/or aspiration-based methods. Adjunctive endovascular procedures, such as balloon angioplasty, stent placement, or intra-arterial thrombolysis, may be used when deemed necessary to achieve or maintain vessel patency. Angiographic reperfusion is assessed duri
• Drug Best Medical Management
  Best medical management consists of comprehensive evidence-based medical therapy for acute ischemic stroke, encompassing acute supportive care, neurological and physiological monitoring, etiological evaluation, and secondary prevention strategies. Standard pharmacological treatments are administered as appropriate, together with risk factor modification and supportive care measures, in accordance with current guideline recommendations. Endovascular recanalization procedures are not included in t

Primary outcome measures

• The rate modified Rankin Scale (mRS) score 0-2 at 90 days [Time frame: 90±14 days after randomization]

Secondary outcome measures (8)

• mRS score as an ordinal scale at 90 days after randomization [Time frame: 90±14 days after randomization]
• The rate of 0-1 and 0-3 mRS scores after randomization for 90 days [Time frame: 90±14 days after randomization]
• National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization [Time frame: 24 (-6/+12) hours after randomization]
• NIHSS score at 7 days after randomization or discharge (whichever occurs first), as well as changes from baseline [Time frame: 7 days after randomization or at discharge]
• European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score 90 days after randomization [Time frame: 90±14 days after randomization]
• Barthel index 95-100 points 90 days after randomization [Time frame: 90±14 days after randomization]
• The recanalization of the basilar artery 24 hours after randomization (confirmed by CTA, MRA, DSA, or TCD) [Time frame: 24 (-6/+12) hours after randomization]
• The technical success rate is defined as the successful recanalization of the target vessel at the end of the surgery (Extended Thrombolysis Classification for Cerebral Infarction [eTICI] 2b-3) [Time frame: At the end of the operation]

Eligibility criteria

Inclusion criteria

• Age≥18
• Acute ischemic stroke in posterior circulation, the time from stroke onset (or finally found normal) to randomization was within 24 hours
• Acute basilar artery occlusion confirmed by CTA,MRA,or DSA
• NIHSS score≥2 points and<10 points from the onset of the disease to before randomization
• Posterior circulation large core infarction:NCCT or DWI showed pc-ASPECTS≥6, or Pons-Midbrain Index (PMI)<3
• No significant functional disability before stroke (mRS≤2 points)
• Each patient or their legal representative must provide written informed consent before enrolment

Exclusion criteria

• Any sign of intracranial hemorrhage (except microbleeds) on brain imaging prior to randomization
• Complete cerebellar infarct with significant mass effect, or bilateral thalamic infarction as evidenced by baseline neuroimaging
• Known or highly suspected chronic occlusion of basilar artery
• History of contraindication for contrast medium (except mild rash)
• CTA/MRA/DSA confirmed occlusion of anterior and posterior circulation
• Severe stenosis, arterial dissection, or excessive tortuosity of the extracranial or intracranial segments of the vertebral artery may result in the inability of interventional instruments to be successfully delivered or positioned
• Current pregnant or breast-feeding
• Refractory hypertension (defined as systolic blood pressure>185 mmHg or diastolic blood pressure>110 mmHg) that cannot be controlled by drug treatment
• Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR>1.5
• Blood glucose<2.8 or>22.2 mmol/L; Platelet count<100\*109/L, serum creatinine>2.0 g/L (177 μ mol/L), or glomerular filtration rate<30 ml/(min\*1.73 m2)
• Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months
• Acute cerebral infarction occurred within 48 hours after cardio cerebral vascular intervention or major surgery (patients over 48 hours can be included in the group)
• Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.)
• Central nervous system vasculitis has been diagnosed or clinically suspected
• Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up
• It is known that patients with dementia or mental illness cannot complete neurological function assessment and follow-up
• Any other condition (in the opinion of the site investigator) that inappropriate to participate this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Tiantan Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT07390032 · HX-A-2025111

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗