The Efficacy and Safety of Endovascular Therapy for Acute Ischemic Stroke Due to Large Core Infarction

Capital Medical University

Status: Not yet enrolling

Conditions: Large Core Infarction; Acute Basilar Artery Occlusion; Endovascular Therapy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07333950

HX-A-2025081

Details and patient eligibility

About

This study assesses the efficacy and safety of endovascular therapy in patients with acute basilar artery occlusion with large core infarction within a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial

Full description

This is a prospective, randomized, open-label, controlled trial designed to compare 90-day clinical outcomes between endovascular therapy (EVT) and best medical management (BMM) in patients with acute posterior circulation large vessel occlusion (LVO) and large core infarction. Eligible patients, aged 18 to 80 years presenting within 24 hours of symptom onset or last known well, must have imaging-confirmed acute basilar artery occlusion and large core infarction, defined as a pc-ASPECTS ≤5 or a Pons-midbrain-index (PMI) ≥ 3 on NCCT or DWI. Participants will be randomly assigned (1:1) to receive EVT or BMM. The primary outcome is functional independence at 90 days, assessed by the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-3. 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: 308 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The age ranged from 18 to 80 years
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. Posterior circulation large core infarction:NCCT or DWI showed pc-ASPECTS≤5, or Pons-Midbrain Index (PMI)≥3
5. NIHSS score ≥10 before randomization
6. Pre-stroke mRS of 0-2
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. Current pregnant or breast-feeding
6. Refractory hypertension (defined as systolic blood pressure>220 mmHg or diastolic blood pressure>110 mmHg) that cannot be controlled by drug treatment;
7. Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up
8. It is known that patients with dementia or mental illness cannot complete neurological function assessment and follow-up
9. Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.)
10. Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months
11. Any other condition (in the opinion of the site investigator) that inappropriate to participate this study
12. CTA/MRA/DSA confirmed occlusion of anterior and posterior circulation
13. Central nervous system vasculitis has been diagnosed or clinically suspected
14. Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR>1.7
15. Blood glucose<2.7 or>22.2 mmol/L; Platelet count<50×109/L, glomerular filtration rate<30ml/min or serum creatinine ≥ 3 mg/dl
16. 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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308 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 posterior circulation vessel 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

Other 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