Basilar Artery Occlusion Chinese Endovascular Trial in Patients With Large Core Infarct

NCT07046299 | Not Yet Recruiting

• 1 other identifier: BAOCHE3
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety and efficacy of endovascular therapy for acute basilar artery occlusion with large core infarcts in a multicenter randomized trial.

Conditions

Basilar Artery Occlusion; Ischemic Stroke; Large Core Infarct

Keywords

Endovascular Therapy; Large Core Infarct; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Achieving mRS 0-3 at 90 Days

  The modified Rankin scale (range, 0 \[no symptoms\] to 6 \[death\]). Higher scores mean a worse outcome.

  90 days

Secondary Outcomes (8)

• Dramatic early favorable response

  24 (-2/+12) hours

• Ordinal Shift analysis of mRS at 90 days

  90 days

• Dichotomized mRS score (0-2 versus 3-6 )

  90 days

• Proportion of Patients Achieving mRS 0-4 at 90 Days

  90 days

• Barthel Index

  90 days

Other Outcomes (3)

• Mortality

  90 days

• Symptomatic intracranial hemorrhage

  24 (-2/+12) hours

• Serious adverse events

  90 days, 12 months, through study completion ( average of 1 year)

Study Arms (2)

Endovascular Therapy Plus Best Medical Treatment

EXPERIMENTAL

Patients randomized to this arm will receive endovascular therapy (EVT) in addition to best medical treatment. EVT must be initiated within 24 hours of symptom onset and completed within 3 hours.The EVT strategy will be selected by the treating neurointerventionalist based on vascular findings. Allowed procedures include mechanical thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, or a combination of these.

Procedure: Endovascular Therapy Plus Best Medical Treatment

Best Medical Treatment Alone

ACTIVE COMPARATOR

Patients in this arm will receive best medical treatment alone in accordance with current stroke guidelines. No endovascular therapy will be performed.

Drug: Best Medical Treatment Alone

Interventions

Endovascular Therapy Plus Best Medical Treatment PROCEDURE

Participants assigned to the endovascular therapy arm will receive EVT in addition to best medical treatment. EVT must be initiated within 24 hours of symptom onset and completed within 3 hours of groin puncture. After evaluating vascular anatomy, neurointerventionalists will determine the most appropriate strategy based on the presence of proximal stenosis, occlusion morphology, and vessel tortuosity. Permitted interventions include mechanical thrombectomy, stent thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, and stent implantation. The choice of treatment approach is left to the discretion of the treating physician, and combinations of techniques are allowed.

Also known as: Mechanical Thrombectomy

Endovascular Therapy Plus Best Medical Treatment

Best Medical Treatment Alone DRUG

Participants in this arm will receive best medical treatment and maximal supportive care according to current stroke guidelines, without the use of mechanical thrombectomy or any intra-arterial intervention.

Best Medical Treatment Alone

Eligibility Criteria

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

You may qualify if:

• Posterior circulation acute ischemic stroke within 24 hours from symptom onset/last seen well.
• Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.
• Patients with large core infarction in the posterior circulation, defined as a posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) score of 3-5 on CT angiography source images or MR with diffusion-weighted imaging or non-contrast CT.
• Age ≥18 and ≤80 years.
• Baseline NIHSS score ≥6 at the time of randomization.
• No significant pre-stroke functional disability (modified Rankin Scale, mRS ≤ 1).
• Informed consent obtained from patient or acceptable patient surrogate.

You may not qualify if:

• Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0.
• Baseline platelet count \< 50000/µL.
• Baseline blood glucose of \< 50mg/dL or \>400mg/dL.
• Severe, sustained hypertension (SBP \> 220 mm Hg or DBP \> 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained below these levels using commonly used medications in China for these purposes (including iv antihypertensive drips), the patient can be enrolled.
• Patients in whom baseline NIHSS can not be obtained by a neurologist or emergency physician prior to sedation or intubation.
• Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
• Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
• History of life threatening allergy (more than rash) to contrast medium.
• Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery .
• Renal insufficiency with creatinine ≥ 3 mg/dL.
• Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
• Subject participating in a study involving an investigational drug or device that would impact this study.
• Known diagnosis or clinical suspicion of cerebral vasculitis.
• Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.
• Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, 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

Central Study Contacts

Xunming Ji

CONTACT

01083198962; jixm@ccmu.edu.cn

Chuanhui Li

CONTACT

15210439828; lichuanhui365@163.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: Professor of Neurology, Xuanwu Hospital, Capital Medical University

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 1, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)