Acute Ischemic StrokeNCT07672795
Endovascular Therapy for Acute Basilar Artery Occlusion With Large Ischemic Core
A study testing Endovascular Therapy and Best Medical Management in people with Acute Ischemic Stroke and Basilar Artery Occlusion, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.
Trial summary
Acute basilar artery occlusion is associated with high mortality and severe disability. Previous randomized trials have demonstrated the benefit of endovascular therapy in selected patients with basilar artery occlusion; however, patients with large ischemic core, commonly defined by low posterior circulation Alberta… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke, Basilar Artery Occlusion, Large Ischemic Core
- What is being tested?
- Endovascular Therapy and Best Medical Management
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical presentation or imaging findings consistent with posterior-circulation ischemic stroke.
- Basilar artery occlusion confirmed by CT angiography (CTA), MR angiography (MRA), or digital subtraction angiography (DSA).
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥10 before randomization.
- Age 18-85 years, inclusive.
- Baseline noncontrast CT, CTA source images, or diffusion-weighted MRI (DWI) demonstrating at least one of the following:
- Posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS) of 0-5; or
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- Pons-Midbrain Index (PMI) >4.
- Randomization within 24 hours of the estimated time of basilar artery occlusion.
- The estimated time of basilar artery occlusion is defined as the sudden onset of stroke symptoms consistent with acute basilar artery occlusion.
- For patients with wake-up stroke or an unknown time of symptom onset, the last known well (LKW) time will be used as the reference time; randomization must occur within 24 hours of LKW.
- Written informed consent provided by the participant or their legally authorized representative.
Who cannot join
- Prestroke modified Rankin Scale (mRS) score ≥3.
- Pregnancy or breastfeeding.
- Allergy to contrast agents or nickel-titanium alloy.
- Current participation in another clinical trial.
- Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg that cannot be controlled with antihypertensive treatment.
- A hereditary or acquired bleeding diathesis, coagulation factor deficiency, or oral anticoagulant use with an international normalized ratio (INR) >3.0.
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- Blood glucose <50 mg/dL (2.8 mmol/L) or >400 mg/dL (22.2 mmol/L), platelet count <50 × 10⁹/L, or hematocrit <25%.
- Life expectancy <1 year.
- Inability to complete the 90-day follow-up, for example because of a lack of a fixed residence or residence overseas that prevents follow-up.
- A documented history of cerebral vasculitis.
- A pre-existing neurological or psychiatric disorder that would interfere with clinical assessment.
- Imaging-Based Exclusion Criteria
- Intracranial hemorrhage on CT or MRI. Patients with cerebral microbleeds <5 mm in diameter detected on MRI may be included.
- Vascular tortuosity, anatomical variation, or arterial dissection on CTA, MRA, or DSA that would make endovascular treatment technically difficult.
- An intracranial tumor, except for a small meningioma.
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, 1 recruiting
- Recruiting
The first affiliated hospital of USTC
Hefei, Anhui, 230001
Chunrong Tao, PhD, 17355055481, chunrongtao@126.com
Chunrong Tao
About this study
Official title: Efficacy and Safety of Endovascular Therapy for Acute Basilar Artery Occlusion With Large Ischemic Core: A Prospective, Multicenter, Randomized Controlled Trial
Acute basilar artery occlusion is associated with high mortality and severe disability. Previous randomized trials have demonstrated the benefit of endovascular therapy in selected patients with basilar artery occlusion; however, patients with large ischemic core, commonly defined by low posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS), remain underrepresented and the benefit-risk profile of endovascular therapy in this subgroup is uncertain.
This prospective, multicenter, randomized, open-label, blinded-endpoint trial will evaluate the efficacy and safety of endovascular therapy plus best medical management compared with best medical management alone in patients with acute basilar artery occlusion within 24 hours from symptom onset or last known well and pc-ASPECTS <7. Eligible participants will be randomized in a 1:1 ratio to receive endovascular therapy plus best medical management or best medical management alone. The primary outcome is favorable functional outcome, defined as a modified Rankin Scale score of 0 to 3 at 90 days.
Read the detailed description
This is a prospective, multicenter, randomized, open-label, parallel-group, blinded-endpoint clinical trial. Patients aged 18 to 80 years with acute posterior circulation ischemic stroke, angiographically confirmed basilar artery occlusion, pc-ASPECTS <7 on CT/CTA source images or MRI-DWI, baseline NIHSS score ≥6, and randomization within 24 hours from symptom onset or last known well will be enrolled.
Participants will be randomly assigned in a 1:1 ratio to either endovascular therapy plus best medical management or best medical management alone. Randomization will be performed using a centralized randomization system with stratified permuted blocks. Stratification factors include study center, baseline NIHSS severity category, and onset-to-randomization time window.
Patients in both groups may receive standard intravenous thrombolysis if eligible according to current guidelines. Endovascular therapy may include stent retriever thrombectomy, direct aspiration thrombectomy, or combined techniques, at the discretion of the treating neurointerventionalist.
The primary efficacy endpoint is the proportion of patients achieving a modified Rankin Scale score of 0 to 3 at 90 days. Secondary endpoints include modified Rankin Scale score of 0 to 2 at 90 days, ordinal shift analysis of the modified Rankin Scale, changes in NIHSS and GCS scores, imaging outcomes, quality of life assessed by EQ-5D, and Barthel Index at 90 days. Safety outcomes include symptomatic intracranial hemorrhage, any intracranial hemorrhage, mortality, procedure-related complications, and serious adverse events.
- Being tested
- Endovascular Therapy, Best Medical Management
- Keywords
- Basilar artery occlusion, Endovascular therapy, Mechanical thrombectomy, Posterior circulation stroke, Large ischemic core
- 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 TherapyProcedure or surgery
Also called Mechanical thrombectomy
Endovascular therapy consists of mechanical thrombectomy using stent retriever, direct aspiration, or combined techniques with the goal of achieving rapid and effective reperfusion of the occluded basilar artery.
Best Medical ManagementOther
Best medical management includes intravenous thrombolysis when eligible, antithrombotic therapy, standard stroke unit care, management of vascular risk factors, blood pressure control, and supportive care according to current clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Therapy Plus Best Medical Management | Experimental | Participants assigned to this group will receive endovascular therapy in addition to best medical management. Endovascular therapy may include stent retriever thrombectomy, direct aspiration thrombectomy, or combined techniques, according to the vascular anatomy, thrombus characteristics, and operator judgment. Eligible patients may receive intravenous thrombolysis before endovascular therapy according to standard clinical guidelines. Receives: Procedure: Endovascular Therapy |
| Best Medical Management Alone | Active comparator | Participants assigned to this group will receive best medical management according to current stroke guidelines. Eligible patients within the intravenous thrombolysis time window may receive standard-dose intravenous thrombolysis. Other medical treatment may include antithrombotic therapy, risk factor management, blood pressure management, and supportive stroke care according to local and guideline-based practice. Receives: Other: Best Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable Functional Outcome at 90 Days
Proportion of participants with a modified Rankin Scale score of 0 to 3 at 90 days. The modified Rankin Scale ranges from 0 to 6, with 0 indicating no symptoms, 5 indicating severe disability, and 6 indicating death.
Measured: 90 days after randomization
Secondary outcomes (5)
Excellent Functional Outcome at 90 Days
Proportion of participants with a modified Rankin Scale score of 0 to 2 at 90 days.
Measured: 90 days after randomization
Successful Recanalization on CTA/MRA
Proportion of participants with successful vascular recanalization on follow-up CTA or MRA.
Measured: Within 72 hours
Ordinal Shift in Modified Rankin Scale Score
Distribution of modified Rankin Scale scores at 90 days analyzed across all ordinal categories.
Measured: 90 days after randomization
Symptomatic Intracranial Hemorrhage
Occurrence of symptomatic intracranial hemorrhage after randomization according to the prespecified trial definition.
Measured: Within 36 hours after randomization
All-cause Mortality
Death from any cause.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Aug 2026
- Primary completion30 Jul 2029 (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 Acute Ischemic StrokeStudies 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
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of China
- Sponsor type
- University, hospital or other
- Collaborators
- Dalian Municipal Central Hospital, Linyi People's Hospital, Fujian Zhangzhou hospital, Shanghai Minhang District Central Hospital
- Responsible party
- Sponsor
- Investigators
- Wei Hu, PhD, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672795
- Sponsor's protocol ID
- USTC-BAO-LARGE-2025KY851
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ndividual participant data will not be publicly shared due to restrictions related to patient privacy, ethics approval, institutional policies, and informed consent. Reasonable requests for de-identified data may be considered after publication of the primary results, subject to approval by the principal investigator and relevant ethics committees.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Endovascular Therapy for Acute Basilar Artery Occlusion With Large Ischemic Core: A Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07672795
- Acronym / sponsor ID
- USTC-BAO-LARGE-2025KY851
- Keywords
- Basilar artery occlusion, Endovascular therapy, Mechanical thrombectomy, Posterior circulation stroke, Large ischemic core
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of ChinaUniversity, hospital or other
- Collaborators
- Dalian Municipal Central Hospital, Linyi People's Hospital, Fujian Zhangzhou hospital, Shanghai Minhang District Central Hospital
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Jun 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.
Acute basilar artery occlusion is associated with high mortality and severe disability. Previous randomized trials have demonstrated the benefit of endovascular therapy in selected patients with basilar artery occlusion; however, patients with large ischemic core, commonly defined by low posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS), remain underrepresented and the benefit-risk profile of endovascular therapy in this subgroup is uncertain.
This prospective, multicenter, randomized, open-label, blinded-endpoint trial will evaluate the efficacy and safety of endovascular therapy plus best medical management compared with best medical management alone in patients with acute basilar artery occlusion within 24 hours from symptom onset or last known well and pc-ASPECTS <7. Eligible participants will be randomized in a 1:1 ratio to receive endovascular therapy plus best medical management or best medical management alone. The primary outcome is favorable functional outcome, defined as a modified Rankin Scale score of 0 to 3 at 90 days.
Detailed description
This is a prospective, multicenter, randomized, open-label, parallel-group, blinded-endpoint clinical trial. Patients aged 18 to 80 years with acute posterior circulation ischemic stroke, angiographically confirmed basilar artery occlusion, pc-ASPECTS <7 on CT/CTA source images or MRI-DWI, baseline NIHSS score ≥6, and randomization within 24 hours from symptom onset or last known well will be enrolled.
Participants will be randomly assigned in a 1:1 ratio to either endovascular therapy plus best medical management or best medical management alone. Randomization will be performed using a centralized randomization system with stratified permuted blocks. Stratification factors include study center, baseline NIHSS severity category, and onset-to-randomization time window.
Patients in both groups may receive standard intravenous thrombolysis if eligible according to current guidelines. Endovascular therapy may include stent retriever thrombectomy, direct aspiration thrombectomy, or combined techniques, at the discretion of the treating neurointerventionalist.
The primary efficacy endpoint is the proportion of patients achieving a modified Rankin Scale score of 0 to 3 at 90 days. Secondary endpoints include modified Rankin Scale score of 0 to 2 at 90 days, ordinal shift analysis of the modified Rankin Scale, changes in NIHSS and GCS scores, imaging outcomes, quality of life assessed by EQ-5D, and Barthel Index at 90 days. Safety outcomes include symptomatic intracranial hemorrhage, any intracranial hemorrhage, mortality, procedure-related complications, and serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular Therapy Plus Best Medical Management | Experimental | Procedure: Endovascular TherapyParticipants assigned to this group will receive endovascular therapy in addition to best medical management. Endovascular therapy may include stent retriever thrombectomy, direct aspiration thrombectomy, or combined techniques, according to the vascular anatomy, thrombus characteristics, and operator judgment. Eligible patients may receive intravenous thrombolysis before endovascular therapy according to standard clinical guidelines. |
| Best Medical Management Alone | Active comparator | Other: Best Medical ManagementParticipants assigned to this group will receive best medical management according to current stroke guidelines. Eligible patients within the intravenous thrombolysis time window may receive standard-dose intravenous thrombolysis. Other medical treatment may include antithrombotic therapy, risk factor management, blood pressure management, and supportive stroke care according to local and guideline-based practice. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Clinical presentation or imaging findings consistent with posterior-circulation ischemic stroke.
- Basilar artery occlusion confirmed by CT angiography (CTA), MR angiography (MRA), or digital subtraction angiography (DSA).
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥10 before randomization.
- Age 18-85 years, inclusive.
- Baseline noncontrast CT, CTA source images, or diffusion-weighted MRI (DWI) demonstrating at least one of the following:
Key exclusion criteria (15 listed)
- Prestroke modified Rankin Scale (mRS) score ≥3.
- Pregnancy or breastfeeding.
- Allergy to contrast agents or nickel-titanium alloy.
- Current participation in another clinical trial.
- Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg that cannot be controlled with antihypertensive treatment.
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 TherapyAlso: Mechanical thrombectomyEndovascular therapy consists of mechanical thrombectomy using stent retriever, direct aspiration, or combined techniques with the goal of achieving rapid and effective reperfusion of the occluded basilar artery. | Procedure or surgery | Endovascular Therapy Plus Best Medical Management |
| Best Medical ManagementBest medical management includes intravenous thrombolysis when eligible, antithrombotic therapy, standard stroke unit care, management of vascular risk factors, blood pressure control, and supportive care according to current clinical guidelines. | Other | Best Medical Management Alone |
Primary outcome
Favorable Functional Outcome at 90 Days
Time frame: 90 days after randomization
Proportion of participants with a modified Rankin Scale score of 0 to 3 at 90 days. The modified Rankin Scale ranges from 0 to 6, with 0 indicating no symptoms, 5 indicating severe disability, and 6 indicating death.
5 secondary outcomes
Excellent Functional Outcome at 90 Days
Time frame: 90 days after randomization
Successful Recanalization on CTA/MRA
Time frame: Within 72 hours
Ordinal Shift in Modified Rankin Scale Score
Time frame: 90 days after randomization
Symptomatic Intracranial Hemorrhage
Time frame: Within 36 hours after randomization
All-cause Mortality
Time frame: 90 days
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 13 Oct 2026.
- Individual participant dataSharing planned: No. ndividual participant data will not be publicly shared due to restrictions related to patient privacy, ethics approval, institutional policies, and informed consent. Reasonable requests for de-identified data may be considered after publication of the primary results, subject to approval by the principal investigator and relevant ethics committees.
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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.
Wei Hu, PhD principal investigator
The First Affiliated Hospital of University of Science and Technology of China
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 Therapy and Best Medical Management in people with Acute Ischemic Stroke and Basilar Artery Occlusion, run by The First Affiliated Hospital of University of Science and Technology of China 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 11 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 13 Oct 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 Chunrong Tao, PhD (+8662284079, chunrongtao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable Functional Outcome at 90 Days (time frame: 90 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 13 Oct 2026.