NCT05631847Completed
Direct Endovascular Treatment Versus Bridging Treatment In Basilar Artery Occlusive Stroke
Endovascular Treatment With Or Without Intravenous Alteplase In Acute Ischemic Stroke Of Basilar Artery Occlusion: A Multicenter, Prospective, Randomized Controlled Trial (BEST-BAO)
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
Currently, both intravenous thrombolysis (IVT) followed by endovascular treatment (EVT) and EVT alone are widely used for the treatment of acute ischemic stroke (AIS) caused by basilar artery occlusion (BAO) (AIS-BAO), but no direct comparison of their efficacy and safety was reported. Only a limited number of cohort and registry studies have preliminarily compared the two strategies in the treatment of AIS-BAO, with results generally indicating that IVT followed by EVT was slightly superior to EVT alone. However, these findings are generally limited by small sample sizes, heterogeneous inclusion and exclusion criteria, different endpoint definitions, and distinct study designs, leading to inconsistent conclusions. Therefore, this study plans to conduct a multicentre, prospective, open-label, blinded endpoint evaluation, randomized controlled trial comparing the efficacy and safety of IVT followed by EVT and EVT alone in the treatment of patients with AIS-BAO who are eligible for both treatment strategies within 4.5 hours of symptom onset. This study intends to include patients with AIS due to BAO fulfilling the following inclusion criteria: patients with AIS caused by BAO confirmed by CTA/MRA/DSA; IVT can be started within 4.5 hours after symptoms onset; Age ≥ 18 years old; NIHSS score ≥ 6. The primary endpoint of the study is the proportion of patients achieving mRS ≤ 2 at 90±14 days after stroke onset.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 345 (actual)
- First submitted
- 20 Nov 2022
- Start date
- 17 Apr 2023
- Primary completion date
- 28 Aug 2025
- Lead sponsor
- Sichuan Academy of Medical Sciences
- Diseases
- Stroke
- NCT number
- NCT05631847
What you commit to
- Study type: Interventional
- Participants enrolled: 345
- From 17 Apr 2023 to the primary completion date, 28 Aug 2025
- 96 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- mRS score \> 2 before this stroke.
Lab values
- Any contraindication to IVT as per the 2019 AHA/ASA guidelines for early management of AIS:
- 1\) Blood pressure \> 185/110 mmHg and cannot be controlled by standard medication, 2) Blood glucose \< 50mg/dL (2.8 mmol/L) or \> 400mg/dL (22.2 mmol/L), 3) Had a cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuroimaging, 4) Severe head trauma in the previous 3 months, 5) Major surgery or severe trauma in the previous 2 weeks, 6) Gastrointestinal or urinary bleeding in the previous 3 weeks, 7) previous intracranial hemorrhage, 8) Using anticoagulants and International normalized ratio (INR) \> 1.7, 9) Known platelet count \< 100 × 109/L, 10) treatment with direct thrombin or factor X inhibitors, 11) Heparin treatment in the previous 48 hours with the activated partial thromboplastin time (APTT) exceeding the upper limit of normal.
- (3) Pregnancy, breastfeeding, or intention to conceive during the study period. (4) Other conditions deemed unsuitable by the investigator.
Who the study is looking for
- A clinical diagnosis of AIS.
- Caused by BAO confirmed by CTA, MRA, or DSA. (BAO is defined as the absence of visualization of the basilar artery on CTA, MRA or DSA. Bilateral vertebral artery occlusions or occlusion of a unilateral vertebral artery that is the sole supplier of the basilar artery, even in the presence of patent basilar artery, will be considered de facto BAO.)
- CT or MRI ruling out intracranial hemorrhage,
- Eligible for IVT and EVT (within 4.5 hours of symptom onset). (Symptoms onset is defined as point in time the patient was last seen well \[at baseline\] if patients are unable to provide a reliable history or the point in time when symptoms have started if patients can provide a reliable history. Symptoms onset includes diplopia, midline ataxia, visual loss, sensory or motor deficits, and conscious disturbance. Isolated vertigo \[not accompanied by dysarthria, motor weakness, sensory symptoms, double vision, depressed level of consciousness\] is not considered onset of symptoms.)
- NIHSS score ≥ 6.
- Age ≥ 18 years.
- Signed informed consent by the patient or legal representative.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (96)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anyang People's Hospital Coordinator of this site? Confirm its status | Anyang | China | Unknown status |
| Bazhong Central Hospital Coordinator of this site? Confirm its status | Bazhong | China | Unknown status |
| Jilin University Sino Japanese Friendship Hospital Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Changde First People's Hospital Coordinator of this site? Confirm its status | Changde | China | Unknown status |
| Chengdu Third People's Hospital Coordinator of this site? Confirm its status | Chengde | China | Unknown status |
| Affiliated Hospital of Chengdu Medical College Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chengdu Second People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chengdu Fifth People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongzhou People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Western Theater General Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sichuan Academy of Medical Sciences sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sichuan Third People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Dayi County People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chengdu First People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chenzhou First People's Hospital Coordinator of this site? Confirm its status | Chenzhou | China | Unknown status |
| Chongqing Yongchuan District People's Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| The First People's Hospital of Liangjiang New Area Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Chongqing Sanbo Chang 'an Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Chongqing University Affiliated S Central Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Chongqing University Medical University Affiliated Yongchuan Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Liangping District People's Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Banan Hospital Affiliated to Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Hechuan District People's Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Deyang People's Hospital Coordinator of this site? Confirm its status | Deyang | China | Unknown status |
| Shifang People's Hospital Coordinator of this site? Confirm its status | Fangting | China | Unknown status |
| Guang'an Central Hospital Coordinator of this site? Confirm its status | Guang’an | China | Unknown status |
| Guangyuan Central Hospital Coordinator of this site? Confirm its status | Guangyuan | China | Unknown status |
| Guangyuan First People's Hospital Coordinator of this site? Confirm its status | Guangyuan | China | Unknown status |
| The Fifth People's Hospital Affiliated to Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Yongkang First People's Hospital Coordinator of this site? Confirm its status | Guli | China | Unknown status |
| Heze Municipal Hospital Coordinator of this site? Confirm its status | Heze | China | Unknown status |
| Huai'an First People's Hospital Coordinator of this site? Confirm its status | Huaian | China | Unknown status |
| Jiaozuo Second People's Hospital Coordinator of this site? Confirm its status | Jiaozuo | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Jilin City | China | Unknown status |
| Jingjiang People's Hospital Coordinator of this site? Confirm its status | Jingjiang | China | Unknown status |
| Jinhua Central Hospital Coordinator of this site? Confirm its status | Jinhua | China | Unknown status |
| Jintang County People's Hospital Coordinator of this site? Confirm its status | Jintang | China | Unknown status |
| Qiandongnan Miao and Dong Autonomous Prefecture People's Hospital Coordinator of this site? Confirm its status | Kaili | China | Unknown status |
| Leshan People's Hospital Coordinator of this site? Confirm its status | Leshan | China | Unknown status |
| Liaocheng Second People's Hospital Coordinator of this site? Confirm its status | Liaocheng | China | Unknown status |
| Linyi Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| Guanghan People's Hospital Coordinator of this site? Confirm its status | Luocheng | China | Unknown status |
| Luoyang Central Hospital Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| Affiliated Traditional Chinese Medicine Hospital of Southwest Hospital Medical University Coordinator of this site? Confirm its status | Luzhou | China | Unknown status |
| Affiliated Hospital of Southwest Medical University Coordinator of this site? Confirm its status | Luzhou | China | Unknown status |
| Maoming County Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Maoming | China | Unknown status |
| Meishan Cardiovascular and Cerebrovascular Disease Hospital Coordinator of this site? Confirm its status | Meishan | China | Unknown status |
| Meishan Second People's Hospital Coordinator of this site? Confirm its status | Meishan | China | Unknown status |
| Meishan Traditional Chinese Medicine Hospital Coordinator of this site? Confirm its status | Meishan | China | Unknown status |
| Mianyang Central Hospital Coordinator of this site? Confirm its status | Mianyang | China | Unknown status |
| Mianyang third people's hospital Coordinator of this site? Confirm its status | Mianyang | China | Unknown status |
| Mianyang 404 Hospital Coordinator of this site? Confirm its status | Mianyang | China | Unknown status |
| Langzhong People's Hospital Coordinator of this site? Confirm its status | Nanchong | China | Unknown status |
| Nanchong Central Hospital Coordinator of this site? Confirm its status | Nanchong | China | Unknown status |
| Yilong County People's Hospital Coordinator of this site? Confirm its status | Nanchong | China | Unknown status |
| Affiliated Hospital of North Sichuan Medical College Coordinator of this site? Confirm its status | Nanchong | China | Unknown status |
| Nanyang Nanshi Hospital Coordinator of this site? Confirm its status | Nanyang | China | Unknown status |
| Nanyang Central Hospital Coordinator of this site? Confirm its status | Nanyang | China | Unknown status |
| Neijiang Second People's Hospital Coordinator of this site? Confirm its status | Neijiang | China | Unknown status |
| Pangang Group General Hospital Coordinator of this site? Confirm its status | Panzhihua | China | Unknown status |
| Panzhihua Central Hospital Coordinator of this site? Confirm its status | Panzhihua | China | Unknown status |
| Pingchang County People's Hospital Coordinator of this site? Confirm its status | Pingchang | China | Unknown status |
| Puyang Oilfield General Hospital Coordinator of this site? Confirm its status | Puyang | China | Unknown status |
| Qujing First People's Hospital Coordinator of this site? Confirm its status | Qujing | China | Unknown status |
| Rizhao traditional Chinese medicine hospital Coordinator of this site? Confirm its status | Rizhao | China | Unknown status |
| Yuebei People's Hospital Coordinator of this site? Confirm its status | Shaoguan | China | Unknown status |
| Suining Central Hospital Coordinator of this site? Confirm its status | Suining | China | Unknown status |
| Suining First People's Hospital Coordinator of this site? Confirm its status | Suining | China | Unknown status |
| The First People's Hospital of Suqian City Coordinator of this site? Confirm its status | Suqian | China | Unknown status |
| The Second Affiliated Hospital of Shandong First Medical University Coordinator of this site? Confirm its status | Taian | China | Unknown status |
| Taizhou People's Hospital Coordinator of this site? Confirm its status | Taizhou | China | Unknown status |
| Taizhou Hospital of Zhejiang Province Coordinator of this site? Confirm its status | Taizhou | China | Unknown status |
| Taizhou First People's Hospital Coordinator of this site? Confirm its status | Taizhou | China | Unknown status |
| Tieling Central Hospital Coordinator of this site? Confirm its status | Tieling | China | Unknown status |
| Xiangtan Central Hospital Coordinator of this site? Confirm its status | Xiangtan | China | Unknown status |
| Xiangyang Central Hospital Coordinator of this site? Confirm its status | Xiangyang | China | Unknown status |
| Liangshan Prefecture Second People's Hospital Coordinator of this site? Confirm its status | Xichang | China | Unknown status |
| Liangshan Prefecture First People's Hospital Coordinator of this site? Confirm its status | Xichang | China | Unknown status |
| Xinxiang Central Hospital Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| Xuzhou Medical University Affiliated Hospital Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Ya 'an People's Hospital Coordinator of this site? Confirm its status | Ya'an | China | Unknown status |
| Yancheng First People's Hospital Coordinator of this site? Confirm its status | Yancheng | China | Unknown status |
| Yibin First People's Hospital Coordinator of this site? Confirm its status | Yibin | China | Unknown status |
| Yibin Second People's Hospital Coordinator of this site? Confirm its status | Yibin | China | Unknown status |
| Yingkou Central Hospital Coordinator of this site? Confirm its status | Yingkou | China | Unknown status |
| Yulin First People's Hospital Coordinator of this site? Confirm its status | Yulin | China | Unknown status |
| Zhangzhou Hospital Coordinator of this site? Confirm its status | Zhangzhou | China | Unknown status |
| Zhengzhou Central Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Zhoukou Central Hospital Coordinator of this site? Confirm its status | Zhoukou | China | Unknown status |
| Zhumadian Central Hospital Coordinator of this site? Confirm its status | Zhumadian | China | Unknown status |
| Zigong Fourth People's Hospital Coordinator of this site? Confirm its status | Zigong | China | Unknown status |
| Zigong Third People's Hospital Coordinator of this site? Confirm its status | Zigong | China | Unknown status |
| Zigong First People's Hospital Coordinator of this site? Confirm its status | Zigong | China | Unknown status |
| Lezhi County People's Hospital Coordinator of this site? Confirm its status | Ziyang | China | Unknown status |
| Ziyang First People's Hospital Coordinator of this site? Confirm its status | Ziyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.