Vertebrobasilar Artery OcclusionNCT07557485
Randomized Clinical Trial of Endovascular Treatment for Progressive Stroke With Vertebrobasilar Artery Occlusion
A study testing Endovascular Recanalization and Medical Therapy Alone in people with Vertebrobasilar Artery Occlusion and Endovascular Treatment, run by Feng Gao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebrobasilar Artery Occlusion, Endovascular Treatment
- What is being tested?
- Endovascular Recanalization and Medical Therapy Alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Known or suspected central nervous system vasculitis.
- Known hereditary or acquired bleeding diathesis, coagulation factor deficiency, current use of oral anticoagulants with an INR >1.5, or active bleeding.
- Blood glucose <2.8 or >22.2 mmol/L; platelet count <100 × 10⁹/L; estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² or serum creatinine ≥177 μmol/L (2.0 mg/dL).
- Any other condition deemed by the site investigator to make the patient unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
Official title: Safety and Efficacy of Endovascular Treatment for Progressive Stroke Due to Vertebrobasilar Artery Occlusion: A Multicenter, Prospective, Open-Label Randomized Controlled Trial With Blinded Endpoint Assessment
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.
Read the detailed description
This multicenter, prospective, open-label, randomized controlled trial with blinded endpoint assessment (PROBE design) was designed to evaluate endovascular treatment (EVT) in patients with progressive stroke due to vertebrobasilar artery occlusion (VBAO). Progressive stroke due to VBAO was defined as vertebrobasilar artery occlusion confirmed by CTA, MRA, or DSA, accompanied by neurological deterioration occurring between 24 hours and 14 days after symptom onset, defined as an increase of ≥4 points in the National Institutes of Health Stroke Scale (NIHSS) score resulting in a total NIHSS score ≥10 in patients with an initial NIHSS score <10. Participants will be randomly assigned in a 1:1 ratio to receive EVT plus medical therapy or medical therapy alone. The primary endpoint is the proportion of patients with good functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 0 to 3. Secondary outcomes include the distribution of mRS scores at 90 days, all-cause mortality at 90 days, and the incidence of symptomatic intracranial hemorrhage (sICH).
- Being tested
- Endovascular Recanalization, Medical Therapy Alone
- Keywords
- Acute Ischemic Stroke, Vertebrobasilar Artery Occlusion, Endovascular Treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular RecanalizationProcedure or surgery
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.
Medical Therapy AloneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Medical Therapy Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90±14 days after randomization
Secondary outcomes (8)
Ordinal shift analysis of mRS score at 90 days after randomization
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.
Measured: 90±14 days after randomization
The proportion of patients achieving mRS scores 0-1 and 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.
Measured: 90±14 days after randomization
The National Institutes of Health Stroke Scale (NIHSS) score at 24 hours
National Institutes of Health Stroke Scale (NIHSS) score at 24 hours after randomization The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Measured: 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
NIHSS score at 7 days after randomization or discharge (whichever came first) The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits.
Measured: 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
European Quality of life 5-Dimension 5-Level (EQ-5D-5L) is a standardized instrument for measuring the general health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
Measured: 90±14 days after randomization
The proportion of Barthel index 95-100 points at 90 days
The proportion of Barthel Index 95-100 at 90 days after randomization.
Measured: 90±14 days after randomization
The recanalization of the vertebrobasilar artery at 24 hours after randomization (confirmed by CTA, MRA, DSA, or TCD)
The recanalization of the vertebrobasilar artery at 24 hours after randomization (confirmed by CTA, MRA, DSA or TCD).
Measured: 24 (-6/+12) hours after randomization
The rate of technical success is defined as the successful recanalization of the target vessel at the end of the procedure (expanded Thrombolysis in Cerebral Infarction scale [eTICI] 2b-3)
Technical success rate, defined as successful recanalization of target vessels at the end of procedure (The expanded Thrombolysis in Cerebral Infarction scale [eTICI] 2b-3).
Measured: At the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebrobasilar Artery OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feng Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Gao, Beijing Tiantan Hospital
- Investigators
- Feng Gao, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557485
- Sponsor's protocol ID
- HX-A-2026012
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Endovascular Treatment for Progressive Stroke Due to Vertebrobasilar Artery Occlusion: A Multicenter, Prospective, Open-Label Randomized Controlled Trial With Blinded Endpoint Assessment
- ClinicalTrials.gov ID
- NCT07557485
- Acronym / sponsor ID
- HX-A-2026012
- Keywords
- Acute Ischemic Stroke, Vertebrobasilar Artery Occlusion, Endovascular Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Feng GaoUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multicenter, prospective, open-label, randomized controlled trial with blinded endpoint assessment (PROBE design) was designed to evaluate endovascular treatment (EVT) in patients with progressive stroke due to vertebrobasilar artery occlusion (VBAO). Progressive stroke due to VBAO was defined as vertebrobasilar artery occlusion confirmed by CTA, MRA, or DSA, accompanied by neurological deterioration occurring between 24 hours and 14 days after symptom onset, defined as an increase of ≥4 points in the National Institutes of Health Stroke Scale (NIHSS) score resulting in a total NIHSS score ≥10 in patients with an initial NIHSS score <10. Participants will be randomly assigned in a 1:1 ratio to receive EVT plus medical therapy or medical therapy alone. The primary endpoint is the proportion of patients with good functional outcome at 90 days, defined as a modified Rankin Scale (mRS) score of 0 to 3. Secondary outcomes include the distribution of mRS scores at 90 days, all-cause mortality at 90 days, and the incidence of symptomatic intracranial hemorrhage (sICH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular Treatment Group | Experimental | Procedure: Endovascular RecanalizationParticipants 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. |
| Medical Therapy Alone Group | Experimental | Drug: Medical Therapy AloneParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular RecanalizationThe 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. | Procedure or surgery | Endovascular Treatment Group |
| Medical Therapy AloneMedical 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. | Drug | Medical Therapy Alone Group |
Primary outcome
The proportion of patients achieving modified Rankin Scale (mRS) score 0-3 at 90 days
Time frame: 90±14 days after randomization
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.
8 secondary outcomes
Ordinal shift analysis of mRS score at 90 days after randomization
Time frame: 90±14 days after randomization
The proportion of patients achieving mRS scores 0-1 and 0-2 at 90 days
Time frame: 90±14 days after randomization
The National Institutes of Health Stroke Scale (NIHSS) score at 24 hours
Time frame: 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
Time frame: 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
Time frame: 90±14 days after randomization
The proportion of Barthel index 95-100 points at 90 days
Time frame: 90±14 days after randomization
The recanalization of the vertebrobasilar artery at 24 hours after randomization (confirmed by CTA, MRA, DSA, or TCD)
Time frame: 24 (-6/+12) hours after randomization
The rate of technical success is defined as the successful recanalization of the target vessel at the end of the procedure (expanded Thrombolysis in Cerebral Infarction scale [eTICI] 2b-3)
Time frame: At the end of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Vertebrobasilar Artery Occlusion
Enrolling by invitationObservational study
Triage of Patients Presenting Beyond 24 Hours With Ischemic Stroke Due to Vertebrobasilar Artery Occlusion
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng Gao, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Recanalization and Medical Therapy Alone in people with Vertebrobasilar Artery Occlusion and Endovascular Treatment, run by Feng Gao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Gao, MD (13581936066, gaofengletter@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients achieving modified Rankin Scale (mRS) score 0-3 at 90 days (time frame: 90±14 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.