Basilar Artery OcclusionBOLTNCT07090941
EVT in Acute Basilar Artery Occlusion With Large Infarction Core
A study testing Endovascular Treatment in people with Basilar Artery Occlusion and Large Ischemic Core, run by The First Affiliated Hospital of Hainan Medical University at 2 sites in China.
Trial summary
A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the efficacy and safety of best medical management (BMM) combined with endovascular treatment (EVT) versus BMM alone in acute basilar artery occlusion (BAO) patients with large infarct cores. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basilar Artery Occlusion, Large Ischemic Core, Large Core Infarct
- What is being tested?
- Endovascular Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2025to 31 Dec 2027
- Phase
- Interventional
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
- 1. Age ≥18 years. 2. Symptoms and signs consistent with basilar artery ischemia. 3. Basilar artery or vertebral artery occlusion confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), digital subtraction angiography (DSA); if vertebral artery occlusion is present, it must completely obstruct blood flow to the basilar artery.
- 4. POST-NIHSS score ≥10 at randomization. 5. Time from symptom onset to randomization ≤24 hours (symptom onset defined as last known well time).
- 6. pc-ASPECTS of 3-5 on CT/MRI (for patients aged <80 years) or pc-ASPECTS of 3-7 (for patients aged ≥80 years).
- 7. Willingness of the patient or legally authorized representative to comply with protocol requirements and data collection procedures, with documented informed consent.
Who cannot join
- 1. Pre-stroke modified Rankin Scale (mRS) score >2. 2. Factors in the target vessel that are expected to prevent completion of endovascular treatment.
- 3. Concurrent anterior and posterior circulation strokes or multivessel occlusions.
- 4. Significant mass effect with imaging or clinical signs of obstructive hydrocephalus or tonsillar herniation.
- 5. Basilar artery occlusion confirmed as chronic by prior imaging or investigator judgment.
- 6. Presence of untreated intracranial aneurysms, intracranial tumors (except small meningiomas), or intracranial vascular malformations.
- 7. Intracranial hemorrhage within the past 6 months, including parenchymal brain hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage.
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- 8. Presence of active bleeding, coagulation disorders, or uncorrectable bleeding tendencies.
- 9. Severe heart, liver, or kidney dysfunction or other severe systemic late-stage diseases.
- 10. Known allergy to iodine contrast agents or other treatment-related drugs. 11. Medically uncontrolled refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg) (Note: Participants can be included if their blood pressure is controllable with medication and maintained at an acceptable level).
- 12. Uncontrollable blood glucose <2.8 mmol/L or >22.2 mmol/L. 13. Pregnancy or breastfeeding. 14. Life expectancy <6 months. 15. Participation in other clinical studies that may affect outcome assessment. 16. Investigator's judgment that the patient is unsuitable for participation in this study or may face significant risks (e.g., due to mental illness, cognitive, or emotional disorders preventing understanding and/or compliance with study procedures and/or follow-up).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570100
Zhengqiang Zhao, PhD, 8613976015677, zhenqiang.zhao@qq.com
- Recruiting
The First Affiliated Hospital of the University of Science and Technology of China
Hefei, Anhui
Wen Sun, PhD, +86 15050589620, sunwen_medneuro@163.com
About this study
Official title: Trial of Endovascular Treatment in Acute Basilar Artery Occlusion Patients With a Large Infarct Core
A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the efficacy and safety of best medical management (BMM) combined with endovascular treatment (EVT) versus BMM alone in acute basilar artery occlusion (BAO) patients with large infarct cores.
Read the detailed description
This trial aims to evaluate whether best medical management (BMM) combined with endovascular treatment (EVT) versus BMM alone improves neurological outcomes in acute basilar artery occlusion (BAO) patients with large infarct cores. A centralized 1:1 simple randomization design assigns participants to receive either EVT or BMM based on randomization results.
- Conditions
- Basilar Artery Occlusion, Large Ischemic Core, Large Core Infarct, Endovascular Treatments
- Being tested
- Endovascular Treatment
- Keywords
- Basilar Artery Occlusion, Endovascular treatment, Large infarct core
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular TreatmentProcedure or surgery
The vascular access route is selected based on the patient's anatomical characteristics and operator discretion. Endovascular treatment (EVT) procedures must adhere to each participating center's standardized operating protocols. Upon confirmation of vascular occlusion, EVT may be performed using devices approved by China's National Medical Products Administration (NMPA). Based on lesion-specific features and operator judgment, permissible techniques include stent retriever thrombectomy, aspiration thrombectomy, balloon angioplasty with or without stenting, or intra-arterial thrombolysis. Investigational devices are strictly prohibited.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Treatment Group | Experimental | Endovascular treatment procedures will be performed in accordance with each center's standard operating protocols. Based on the characteristics of vascular lesions and clinical judgment, investigators may select appropriate interventions for stenosis or occlusion, including stent retriever thrombectomy, aspiration thrombectomy, balloon angioplasty, stenting, intra-arterial thrombolysis, or various combinations of these methods. Receives: Procedure: Endovascular Treatment |
| Best Medical Management Group | No intervention | Participants receive the best medical management only. Best Medical Treatment and maximum supportive care according to local guidelines, not including mechanical thrombectomy or intra-arterial treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shift analysis of the improvement trend in modified Rankin Scale (mRS) scores at 90 (±7) days after randomization.
Shift analysis is a statistical method used to evaluate the overall distribution change in modified Rankin Scale (mRS) scores, assessing whether an intervention leads to a general shift toward better outcomes across all score categories.
Measured: 90 (±7) days after randomization
Secondary outcomes (5)
Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 (±7) days after randomization.
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Measured: 90 (±7)days after randomization
Proportion of patients with a modified Rankin Scale (mRS) score of 0-2 at 90 (±7) days after randomization.
The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.
Measured: 90 (±7) days after randomization
Change in Posterior National Institutes of Health Stroke Scale (POST-NIHSS) from baseline at 24 hours after randomization
The Posterior National Institutes of Health Stroke Scale (POST-NIHSS) is a tool used to assess the severity of stroke symptoms by evaluating various neurological functions, such as consciousness, vision, movement, and speech. The POST-NIHSS ranges from 0 to 52, with higher scores indicating more severe neurological deficits and a worse clinical condition.The score helps in gauging the degree of impairment caused by a stroke.
Measured: 24 hours after randomization
Change in Posterior National Institutes of Health Stroke Scale (POST-NIHSS) from baseline at discharge or 7±1 days after randomization.
The Posterior National Institutes of Health Stroke Scale (POST-NIHSS) is a tool used to assess the severity of stroke symptoms by evaluating various neurological functions, such as consciousness, vision, movement, and speech. The POST-NIHSS ranges from 0 to 52, with higher scores indicating more severe neurological deficits and a worse clinical condition.The score helps in gauging the degree of impairment caused by a stroke.
Measured: Discharge or 7±1 days after randomization
Successful reperfusion (modified Thrombolysis in Cerebral Infarction [mTICI] score, 2b-3)
Reperfusion was assessed using the modified Thrombolysis in Cerebral Infarction (mTICI) scale, which ranges from grade 0 (no perfusion) to grade 3 (complete reperfusion), with higher grades indicating greater reperfusion and therefore a better angiographic outcome.
Measured: At the end of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Aug 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basilar 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
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Hainan Medical University
- Sponsor type
- Other government
- Collaborators
- Heyuan Shenhe People's Hospital, Wuhan No.1 Hospital, People's Hospital of Lixin Country, The Eighth Affiliated Hospital of Southern Medical University, Longyan City First Hospital, People's Hospital of Guoyang County, Maoming Hospital of Traditional Chinese Medicine, The Central Hospital of Xiangtan, The Fourth Hospital of Liuan, Wuwei City People's Hospital, Dongguan People's Hospital, Jingmen Central Hospital, Wuhu City Second People's Hospital, Zhongshan Hospital Of Traditional Chinese Medicine, The First Hospital of Putian City, Yijishan Hospital, Liaocheng People's Hospital, People's Hospital of Dongxihu District, First People's Hospital of Yulin, Wuhan Central Hospital, Tongliao People's Hospital, Huaibei Miner General Hospital, Huaibei, China., The First People's Hospital of Zhangjiagang, Guangdong Second Provincial General Hospital, The affiliated Changsha Hospital of Xiangya School of Medicine, Central South University, Wangjiang People's Hospital of Anhui Province, The Third Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Nanchang University, Maanshan People's Hospital, People's Hospital of Yingshang County, Haiyan People's Hospital, The First Affiliated Hospital of the University of Science and Technology of China
- Responsible party
- Principal investigator, zhaozhenqiang, The First Affiliated Hospital of Hainan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090941
- Sponsor's protocol ID
- BOLT
- Acronym
- BOLT
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes