Randomized Clinical Trial of Endovascular Treatment for Progressive Stroke With Vertebrobasilar Artery Occlusion

NCT07557485 | Not Yet Recruiting DMC

• 1 other identifier: HX-A-2026012
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter, prospective, open-label randomized controlled trial with blinded assessment was designed to assess the efficacy and safety of endovascular treatment for progressive stroke due to vertebrobasilar artery occlusion.

Conditions

Endovascular Treatment; Vertebrobasilar Artery Occlusion

Keywords

Acute Ischemic Stroke; Vertebrobasilar Artery Occlusion; Endovascular Treatment

Outcome Measures

Primary Outcomes (1)

• The proportion of patients achieving modified Rankin Scale (mRS) score 0-3 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)

• Ordinal shift analysis of mRS score at 90 days after randomization

  90±14 days after randomization

• The proportion of patients achieving mRS scores 0-1 and 0-2 at 90 days

  90±14 days after randomization

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

  24 (-6/+12) hours after randomization

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

  7 days after randomization or at discharge

• The score on the European Quality of life 5-Dimension 5-Level (EQ-5D-5L) patient-reported questionnaire score at 90 days

  90±14 days after randomization

Other Outcomes (5)

• The rate of mortality within 90 days after randomization

  90±14 days after randomization

• The incidence of any symptomatic intracranial hemorrhage (sICH) defined as the Heidelberg classification within 24 hours

  24 (-6/+12) hours after randomization

• The rate of any intracranial hemorrhage identified by CT or MRI imaging within 24 hours

  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 medical therapy. The procedure aims to achieve recanalization of the occluded vertebrobasilar 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 neurointerventionalists.

Procedure: Endovascular Recanalization

Medical Therapy Alone Group

EXPERIMENTAL

Participants randomized to this arm will receive medical therapy 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: Medical Therapy Alone

Interventions

Endovascular Recanalization PROCEDURE

The endovascular approach is selected by the treating neurointerventionalists 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 deployment, or intraarterial 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 therapy is individualized according to stroke mechanism, procedural findings, and post-treatment imaging.

Endovascular Treatment Group

Medical Therapy Alone DRUG

Medical therapy 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.

Medical Therapy Alone 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 years.
• Acute ischemic stroke, with a National Institutes of Health Stroke Scale (NIHSS) score of \<10 at initial symptom onset, and no prior endovascular treatment.
• Stroke progression occurring from 24 hours to 14 days after initial symptom onset, defined as an NIHSS score of ≥10 with an increase of ≥4 points from baseline.
• Acute basilar artery occlusion or dominant vertebral artery occlusion with contralateral occlusion or hypoplasia, confirmed by CTA, MRA or DSA.
• Posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS) of ≥6 and Pons-Midbrain Index (PMI) of ≤3 on CT or diffusion-weighted imaging (DWI).
• Randomization within 24 hours of stroke progression.
• Pre-stroke mRS score of 0-2.
• Provision of signed informed consent by the patient or their legal representative.

You may not qualify if:

• Any sign of intracranial hemorrhage (except microbleeds) on baseline brain imaging.
• Imaging confirms the progression of symptoms caused by intracranial hemorrhage, brain edema, or other clear causes.
• Extensive cerebellar infarction with significant mass effect or bilateral thalamic infarction on baseline neuroimaging.
• Presence of untreated intracranial aneurysm, intracranial tumor (except small meningioma and aneurysms \<3 mm in diameter), or intracranial arteriovenous malformation.
• Known or highly suspected chronic responsible artery occlusion.
• Presence of severe stenosis in the extracranial or intracranial segment of the responsible artery, arterial dissection, or excessive vascular tortuosity that may prevent successful delivery or navigation of endovascular devices.
• Known contraindication to contrast medium (except mild rash).
• Refractory hypertension not controlled by medication, defined as systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg.
• Known pregnancy or lactation, or a positive pregnancy test prior to randomization.
• Known dementia or psychiatric disease precluding completion of neurological assessment and follow-up.
• Life expectancy \<1 year, including patients with malignancy or advanced cardiopulmonary disease.
• Current participation in any other clinical trial of drugs or medical devices, or anticipated participation in another such trial within 3 months after enrollment.
• Acute ischemic stroke within 48 hours after cardiovascular or cerebrovascular interventional treatment or major surgery; patients presenting \>48 hours after such procedures were eligible.
• Recent (within 1 month) gastrointestinal or genitourinary bleeding, acute myocardial infarction, or traumatic brain injury.
• Multivessel severe stenosis or occlusion confirmed by CTA, MRA, or DSA.

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

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)