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Comparing two treatments for 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)

Not applicable Interventional Sichuan Academy of Medical Sciences · NCT05631847

This study is testing whether a combination of two treatments for a type of stroke caused by a blocked basilar artery works better than using just one of those treatments alone.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment340 (estimated)
Ages18 Years and up
SexAll
SponsorSichuan Academy of Medical Sciences Academic / other
Locations85 sites (Hefei, Anhui and 84 other locations)
Trial IDNCT05631847 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the efficacy and safety of intravenous thrombolysis (IVT) followed by endovascular treatment (EVT) against EVT alone in patients suffering from acute ischemic stroke caused by basilar artery occlusion. The study will be conducted as a multicenter, prospective, open-label, blinded endpoint evaluation, randomized controlled trial. It seeks to address the current lack of direct comparisons between these two treatment strategies, which have shown varying results in previous studies. By enrolling eligible patients within 4.5 hours of symptom onset, the trial will provide valuable insights into the best treatment approach for this severe condition.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with acute ischemic stroke caused by basilar artery occlusion who are eligible for both intravenous thrombolysis and endovascular treatment.

Not a fit: Patients who have contraindications for thrombolysis or those with intracranial hemorrhage will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for patients with acute ischemic stroke due to basilar artery occlusion, potentially enhancing recovery and reducing mortality rates.

How similar studies have performed: While previous studies have suggested that IVT followed by EVT may be superior, this trial is novel in its direct comparison of these two treatment strategies in a randomized controlled setting.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

1. A clinical diagnosis of AIS.
2. 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.)
3. CT or MRI ruling out intracranial hemorrhage,
4. 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.)
5. NIHSS score ≥ 6.
6. Age ≥ 18 years.
7. Signed informed consent by the patient or legal representative.

Exclusion criteria:

1. mRS score \> 2 before this stroke.
2. 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.

Where this trial is running

Hefei, Anhui and 84 other locations

+35 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Ischemic StrokeBasilar Artery OcclusionThrombosisAlteplaseEndovascular TreatmentEndovascular treatmentAcute ischemic strokeBasilar artery occlusion
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.