The Efficacy and Safety of Endovascular Treatment for Acute Mild Basilar Artery Occlusion

NCT07390032 | Not Yet Recruiting DMC

• 1 other identifier: HX-A-2025111
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses the efficacy and safety of endovascular treatment for acute mild basilar artery occlusion within a multicenter, prospective, open-label, endpoint-blinded, randomized controlled clinical trial.

Conditions

Acute Mild Basilar Artery Occlusion; Basilar Artery Occlusion; Endovascular Treatment

Keywords

Acute Ischemic Stroke; Acute Mild Basilar Artery Occlusion; Basilar Artery Occlusion; Endovascular Treatment

Outcome Measures

Primary Outcomes (1)

• The rate modified Rankin Scale (mRS) score 0-2 at 90 days

  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 (8)

• mRS score as an ordinal scale at 90 days after randomization

  90±14 days after randomization

• The rate of 0-1 and 0-3 mRS scores after randomization for 90 days

  90±14 days after randomization

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

  24 (-6/+12) hours after randomization

• NIHSS score at 7 days after randomization or discharge (whichever occurs first), as well as changes from baseline

  7 days after randomization or at discharge

• European Five Dimensional Health Scale Level 5 (EQ-5D-5L) score 90 days after randomization

  90±14 days after randomization

Other Outcomes (5)

• Mortality rate within 90 days after randomization

  90±14 days after randomization

• Rate of any Symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification within 24 hours of randomization

  24 (-6/+12) hours after randomization

• Rate of any intracranial hemorrhage identified by CT or MRI imaging within 24 hours after randomization

  24 hours 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 basilar artery 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

EXPERIMENTAL

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

You may qualify if:

• Age≥18
• 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
• NIHSS score≥2 points and\<10 points from the onset of the disease to before randomization
• Posterior circulation large core infarction:NCCT or DWI showed pc-ASPECTS≥6, or Pons-Midbrain Index (PMI)\<3
• No significant functional disability before stroke (mRS≤2 points)
• 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)
• CTA/MRA/DSA confirmed occlusion of anterior and posterior circulation
• Severe stenosis, arterial dissection, or excessive tortuosity of the extracranial or intracranial segments of the vertebral artery may result in the inability of interventional instruments to be successfully delivered or positioned
• Current pregnant or breast-feeding
• Refractory hypertension (defined as systolic blood pressure\>185 mmHg or diastolic blood pressure\>110 mmHg) that cannot be controlled by drug treatment
• Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR\>1.5
• Blood glucose\<2.8 or\>22.2 mmol/L; Platelet count\<100\*109/L, serum creatinine\>2.0 g/L (177 μ mol/L), or glomerular filtration rate\<30 ml/(min\*1.73 m2)
• Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months
• 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)
• Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.)
• Central nervous system vasculitis has been diagnosed or clinically suspected
• Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up

Sponsors & Collaborators

• Feng Gao: 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

  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: SPONSOR INVESTIGATOR
• PI Title: Vice-Director of Interventional Neuroradiology, Department of Neurology

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)