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

NCT07333950 | Not Yet Recruiting DMC

• 1 other identifier: HX-A-2025081
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Basilar Artery Occlusion; Endovascular Therapy; Large Core Infarction

Keywords

Ischemic Stroke; Acute Basilar Artery Occlusion; Endovascular Therapy; Large Core Infarction

Outcome Measures

Primary Outcomes (1)

• Rate of modified Rankin scale 0-3 at 90 (±14) days after randomization

  The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.

  90±14 days after randomization

Secondary Outcomes (9)

• MRS score as an ordinal scale at 90 (±14) days after randomization

  90±14 days after randomization

• Rate of mRS 0-2 at 90 (±14) days after randomization

  90±14 days after randomization

• National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization

  24 hours after randomization

• NIHSS score at 7 days after randomization or discharge (whichever came first)

  7 days after randomization or at discharge

• Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after randomization

  90±14 days after randomization

Other Outcomes (4)

• Rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification within 18-36 hours of randomization

  18-36 hours after randomization

• Rate of any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours after randomization

  Any intracranial hemorrhage identified by CT or MRI imaging within 18-36 hours

• All cause of mortality within 7 days after randomization

  7 days after randomization

Study Arms (2)

Endovascular Treatment Group

EXPERIMENTAL

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.

Procedure: Endovascular Recanalization Strategy

Best Medical Management Group

OTHER

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.

Drug: Best Medical Management

Interventions

Endovascular Recanalization Strategy PROCEDURE

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.

Endovascular Treatment Group

Best Medical Management DRUG

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.

Best Medical Management Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age ranged from 18 to 80 years
• 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
• Posterior circulation large core infarction:NCCT or DWI showed pc-ASPECTS≤5, or Pons-Midbrain Index (PMI)≥3
• NIHSS score ≥10 before randomization
• Pre-stroke mRS of 0-2
• Each patient or their legal representative must provide written informed consent before enrolment

You may not qualify if:

• 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)
• Current pregnant or breast-feeding
• Refractory hypertension (defined as systolic blood pressure\>220 mmHg or diastolic blood pressure\>110 mmHg) that cannot be controlled by drug treatment;
• 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
• Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.)
• Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months
• Any other condition (in the opinion of the site investigator) that inappropriate to participate this study
• CTA/MRA/DSA confirmed occlusion of anterior and posterior circulation
• Central nervous system vasculitis has been diagnosed or clinically suspected
• Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR\>1.7
• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Feng Gao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Gao, MD

CONTACT

13581936066; gaofengletter@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Director of Interventional Neuroradiology, Department of Neurology

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)