Endovascular Therapy for Acute Basilar Artery Occlusion With Large Ischemic Core

NCT07672795 | Not Yet Recruiting DMC

• 1 other identifier: USTC-BAO-LARGE-2025KY851
• Study Type: interventional
• Target: 256
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acute basilar artery occlusion is associated with high mortality and severe disability. Previous randomized trials have demonstrated the benefit of endovascular therapy in selected patients with basilar artery occlusion; however, patients with large ischemic core, commonly defined by low posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS), remain underrepresented and the benefit-risk profile of endovascular therapy in this subgroup is uncertain. This prospective, multicenter, randomized, open-label, blinded-endpoint trial will evaluate the efficacy and safety of endovascular therapy plus best medical management compared with best medical management alone in patients with acute basilar artery occlusion within 24 hours from symptom onset or last known well and pc-ASPECTS \<7. Eligible participants will be randomized in a 1:1 ratio to receive endovascular therapy plus best medical management or best medical management alone. The primary outcome is favorable functional outcome, defined as a modified Rankin Scale score of 0 to 3 at 90 days.

Conditions

Acute Ischemic Stroke; Basilar Artery Occlusion; Large Ischemic Core

Keywords

Basilar artery occlusion; Endovascular therapy; Mechanical thrombectomy; Posterior circulation stroke; Large ischemic core

Outcome Measures

Primary Outcomes (1)

• Favorable Functional Outcome at 90 Days

  Proportion of participants with a modified Rankin Scale score of 0 to 3 at 90 days. The modified Rankin Scale ranges from 0 to 6, with 0 indicating no symptoms, 5 indicating severe disability, and 6 indicating death.

  90 days after randomization

Secondary Outcomes (5)

• Excellent Functional Outcome at 90 Days

  90 days after randomization

• Successful Recanalization on CTA/MRA

  Within 72 hours

• Ordinal Shift in Modified Rankin Scale Score

  90 days after randomization

• Symptomatic Intracranial Hemorrhage

  Within 36 hours after randomization

• All-cause Mortality

  90 days

Study Arms (2)

Endovascular Therapy Plus Best Medical Management

EXPERIMENTAL

Participants assigned to this group will receive endovascular therapy in addition to best medical management. Endovascular therapy may include stent retriever thrombectomy, direct aspiration thrombectomy, or combined techniques, according to the vascular anatomy, thrombus characteristics, and operator judgment. Eligible patients may receive intravenous thrombolysis before endovascular therapy according to standard clinical guidelines.

Procedure: Endovascular Therapy

Best Medical Management Alone

ACTIVE COMPARATOR

Participants assigned to this group will receive best medical management according to current stroke guidelines. Eligible patients within the intravenous thrombolysis time window may receive standard-dose intravenous thrombolysis. Other medical treatment may include antithrombotic therapy, risk factor management, blood pressure management, and supportive stroke care according to local and guideline-based practice.

Other: Best Medical Management

Interventions

Endovascular Therapy PROCEDURE

Endovascular therapy consists of mechanical thrombectomy using stent retriever, direct aspiration, or combined techniques with the goal of achieving rapid and effective reperfusion of the occluded basilar artery.

Also known as: Mechanical thrombectomy

Endovascular Therapy Plus Best Medical Management

Best Medical Management OTHER

Best medical management includes intravenous thrombolysis when eligible, antithrombotic therapy, standard stroke unit care, management of vascular risk factors, blood pressure control, and supportive care according to current clinical guidelines.

Best Medical Management Alone

Eligibility Criteria

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

You may qualify if:

• Clinical symptoms or imaging findings suggestive of acute posterior circulation ischemic stroke.
• Basilar artery occlusion confirmed by CTA, MRA, or DSA.
• Posterior circulation ASPECTS \<7 on CT, CTA source images, or MRI-DWI.
• Age 18 to 80 years.
• Time from symptom onset or last known well to randomization within 24 hours.
• Written informed consent obtained from the patient or legally authorized representative.
• Baseline NIHSS score ≥6 before randomization.

You may not qualify if:

• Pre-stroke modified Rankin Scale score ≥3.
• Pregnancy or lactation.
• Known allergy to contrast agents or nickel-titanium alloy.
• Current participation in another clinical trial.
• Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg that cannot be controlled with antihypertensive therapy.
• Known hereditary or acquired bleeding diathesis, coagulation factor deficiency, or current oral anticoagulant use with INR \>1.7.
• Blood glucose \<50 mg/dL or \>400 mg/dL, platelet count \<50 × 10\^9/L, or hematocrit \<25%.
• Life expectancy less than 1 year.
• Inability to complete 90-day follow-up.
• Definite history of cerebral vasculitis.
• Pre-existing neurological or psychiatric disorder that may interfere with neurological or functional assessment.
• Intracranial hemorrhage on CT or MRI, except for cerebral microbleeds \<5 mm on MRI.
• Vascular tortuosity, anatomical variation, or arterial dissection on CTA, MRA, or DSA that precludes endovascular treatment.
• Intracranial tumor, except for small meningioma.

Sponsors & Collaborators

• Dalian Municipal Central Hospital: collaborator
• Linyi People's Hospital: collaborator
• Fujian Zhangzhou hospital: collaborator
• Shanghai Minhang District Central Hospital: collaborator
• The First Affiliated Hospital of University of Science and Technology of China: lead

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

• Wei Hu, PhD

  The First Affiliated Hospital of University of Science and Technology of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunrong Tao, PhD

CONTACT

+8662284079; chunrongtao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of endovascular therapy, treating physicians and participants will not be masked to treatment assignment. Outcome assessors for the 90-day modified Rankin Scale and the independent imaging core laboratory will be blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share