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

Feng Gao

Status: Begins enrollment this month

Conditions: Basilar Artery Occlusion; Endovascular Treatment; Acute Mild Basilar Artery Occlusion

Treatments: Drug: Best Medical Management; Procedure: Endovascular Recanalization Strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT07390032

HX-A-2025111

Details and patient eligibility

About

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.

Full 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).

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Any sign of intracranial hemorrhage (except microbleeds) on brain imaging prior to randomization
2. Complete cerebellar infarct with significant mass effect, or bilateral thalamic infarction as evidenced by baseline neuroimaging
3. Known or highly suspected chronic occlusion of basilar artery
4. History of contraindication for contrast medium (except mild rash)
5. CTA/MRA/DSA confirmed occlusion of anterior and posterior circulation
6. 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
7. Current pregnant or breast-feeding
8. Refractory hypertension (defined as systolic blood pressure>185 mmHg or diastolic blood pressure>110 mmHg) that cannot be controlled by drug treatment
9. Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR>1.5
10. 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)
11. Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months
12. 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)
13. Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.)
14. Central nervous system vasculitis has been diagnosed or clinically suspected
15. Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up
16. It is known that patients with dementia or mental illness cannot complete neurological function assessment and follow-up
17. Any other condition (in the opinion of the site investigator) that inappropriate to participate this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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230 participants in 2 patient groups

Endovascular Treatment Group

Experimental group

Description:

Participants randomized to the endovascular recanalization arm will receive endovascular treatment in addition to best medical management. The procedure aims to achieve recanalization of the occluded basilar artery using mechanical thrombectomy techniques, including stent retriever and/or aspiration-based approaches. When necessary, adjunctive endovascular measures may be performed as rescue therapy at the discretion of the treating neurointerventionalist.

Treatment:

Procedure: Endovascular Recanalization Strategy

Best Medical Management Group

Experimental group

Description:

Participants randomized to this arm will receive best medical management alone, consistent with current guideline recommendations for the acute and secondary prevention phases of ischemic stroke. No endovascular recanalization procedures are permitted after randomization.

Treatment:

Drug: Best Medical Management