Basilar Artery Occlusion Chinese Endovascular Trial in Patients With Large Core Infarct (BAOCHE3)

Safety and Efficacy of Endovascular Therapy for Acute Basilar Artery Occlusion With Large Core Infarct: A Prospective, Multicenter, Randomized, Open-Label Controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Stroke; Basilar Artery Occlusion; Large Core Infarct
• Intervention / Treatment: Procedure: Endovascular Therapy Plus Best Medical Treatment; Drug: Best Medical Treatment Alone

Detailed Description

This is a prospective, randomized, open-label, controlled trial evaluating endovascular therapy (EVT) for patients with acute basilar artery occlusion (BAO) and large core infarcts, defined by a pc-ASPECTS score of 3-5 on DWI or CT. Eligible participants aged 18-80 years and presenting within 24 hours of symptom onset will be randomly assigned in a 1:1 ratio to receive either EVT plus standard medical therapy or medical therapy alone. Randomization will be stratified by age, baseline NIHSS, and onset-to-treatment time. The primary outcome is the proportion of patients achieving functional independence (mRS 0-3) at 90 days. Secondary outcomes include neurological improvement, mRS distribution, quality of life, and 90-day all-cause mortality, and the incidence of symptomatic intracranial hemorrhage (sICH). This study aims to generate high-quality evidence to guide treatment strategies for patients with acute basilar artery occlusion and large core infarcts.

• Study Type: Interventional
• Enrollment (Estimated): 314
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chuanhui Li; Phone Number: 15210439828; Email: lichuanhui365@163.com
• Study Contact Backup: Name: Xunming Ji; Phone Number: 01083198962; Email: jixm@ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital
      • Contact: Xunming Ji; Phone Number: 01083198962; Email: jixm@ccmu.edu.cn
      • Contact: Chuanhui Li; Phone Number: +8615210439828; Email: lichuanhui365@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Posterior circulation acute ischemic stroke within 24 hours from symptom onset/last seen well.
2. Occlusion (TIMI 0-1) of the basilar artery or intracranial segments of both vertebral arteries (V4) as evidenced by CTA/MRA/DSA.
3. 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.
4. Age ≥18 and ≤80 years.
5. Baseline NIHSS score ≥6 at the time of randomization.
6. No significant pre-stroke functional disability (modified Rankin Scale, mRS ≤ 1).
7. Informed consent obtained from patient or acceptable patient surrogate.

Exclusion Criteria:

Clinical exclusion criteria:

1. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0.
2. Baseline platelet count < 50000/µL.
3. Baseline blood glucose of < 50mg/dL or >400mg/dL.
4. 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.
5. Patients in whom baseline NIHSS can not be obtained by a neurologist or emergency physician prior to sedation or intubation.
6. Seizures at stroke onset which would preclude obtaining a baseline NIHSS.
7. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
8. History of life threatening allergy (more than rash) to contrast medium.
9. Patients with acute stroke within the first 48 hours after percutaneous cardiac, cerebrovascular interventions and major surgery .
10. Renal insufficiency with creatinine ≥ 3 mg/dL.
11. Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
12. Subject participating in a study involving an investigational drug or device that would impact this study.
13. Known diagnosis or clinical suspicion of cerebral vasculitis.
14. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.

15. Unlikely to be available for 90 days follow-up (e.g. no fixed home address, visitor from overseas).

    Neuroimaging exclusion criteria:

16. Pons-midbrain-index of ≥ 4 on CT angiography source images or MR with diffusion-weighted imaging or non-contrast CT.
17. CT or MR evidence of hemorrhage (the presence of microbleeds on MRI is allowed).
18. Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the fourth ventricle.
19. Complete bilateral thalamic infarction on CT or MRI.
20. Evidence of vertebral occlusion, high grade stenosis or arterial dissection in the extracranial or intracranial segment that cannot be treated or will prevent access to the intracranial clot or excessive tortuosity of cervical vessels precluding device delivery/deployment.
21. Subjects with occlusions in both anterior and posterior circulation.
22. Evidence of intracranial tumor (except small meningioma).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endovascular Therapy Plus Best Medical Treatment; 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; 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.; Other Names: Mechanical Thrombectomy
Active Comparator: Best Medical Treatment Alone; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dramatic early favorable response	Dramatic early favorable response as determined by an National Institute of Health stroke scale (NIHSS) of 0-2 or NIHSS improvement ≥ 8 points at 24 (-2/+12) hours.	24 (-2/+12) hours
Dichotomized mRS score (0-2 versus 3-6 )	The modified Rankin scale (range, 0 [no symptoms] to 6 [death])	90 days
Ordinal Shift analysis of mRS at 90 days	The modified Rankin scale (range, 0 [no symptoms] to 6 [death])	90 days
Proportion of Patients Achieving mRS 0-4 at 90 Days	The modified Rankin scale (range, 0 [no symptoms] to 6 [death])	90 days
Barthel Index	The Barthel Index ranges from a minimum of 0 to a maximum of 100, with higher scores indicating better outcomes.	90 days
Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 6 months	The modified Rankin scale (range, 0 [no symptoms] to 6 [death])	6 months
Proportion of patients achieving favourable outcomes defined as mRS 0-3 at 12 months	The modified Rankin scale (range, 0 [no symptoms] to 6 [death])	12 months
Proportion of basilar artery recanalization	Vessel recanalization at 24 hours (-2/+12 hours) in both treatment groups assessed by using Arterial Occlusive Lesion (AOL) grades	24 hours (-2/+12 hours)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		90 days
Symptomatic intracranial hemorrhage		24 (-2/+12) hours
Serious adverse events	All serious adverse events during follow-up in all randomized patients.	90 days, 12 months, through study completion ( average of 1 year)

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: June 18, 2025
• First Submitted That Met QC Criteria: June 29, 2025
• First Posted (Estimated): July 1, 2025

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 29, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Endovascular Therapy; Large Core Infarct
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Necrosis; Ischemia; Stroke; Ischemic Stroke; Infarction; Arterial Occlusive Diseases
• Other Study ID Numbers: BAOCHE3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study is proceeding.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No