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NCT07333950

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

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

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

Official title: The Efficacy and Safety of Endovascular Therapy for Acute Ischemic Stroke Due to Large Core Infarction -- A Multicenter, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

308

Start Date

2026-01-01

Completion Date

2028-12-31

Last Updated

2026-01-12

Healthy Volunteers

Conditions

Acute Basilar Artery Occlusion Endovascular Therapy Large Core Infarction

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 during the procedure, and treatment is terminated once adequate revascularization is obtained. Subsequent medical management is individualized according to stroke mechanism, procedural findings, and post-treatment imaging.

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 this treatment strategy.

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)

Locations (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China