NCT05631847|CompletedDMC

Direct Endovascular Treatment Versus Bridging Treatment In Basilar Artery Occlusive Stroke

BEST-BAO

Endovascular Treatment With Or Without Intravenous Alteplase In Acute Ischemic Stroke Of Basilar Artery Occlusion: A Multicenter, Prospective, Randomized Controlled Trial (BEST-BAO)

Sichuan Academy of Medical Sciences ClinicalTrials.gov

Compare

1 other identifier

GFQ18981838913

Study Type

interventional

Target

345

Locations

1 country

Sites

Timeline

RegisteredNov 2022

StartedApr 2023

CompletionAug 2025

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

345

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach

1 country

96 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

November 20, 2022

Completed

10 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed

5 months until next milestone

Study Start

First participant enrolled

April 17, 2023

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2025

Completed

Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

2.4 years

First QC Date

November 20, 2022

Last Update Submit

November 19, 2025

Conditions

Acute Ischemic Stroke Basilar Artery Occlusion Thrombosis Alteplase Endovascular Treatment

Keywords

Endovascular treatmentAlteplaseAcute ischemic strokeBasilar artery occlusionIntravenous thrombosis

Outcome Measures

Primary Outcomes (1)

Proportion of patients achieving mRS ≤ 2.
The mRS is an ordinal scale ranging from 0 to 6, where higher scores indicate a greater degree of disability.
At 90±14 days after stroke onset.

Secondary Outcomes (17)

Proportions of patients with mRS = 0 or 1.
At 90±14 days after stroke onset.
Proportions of patients with mRS = 0-3.
At 90±14 days after stroke onset
The mRS score.
At 90±14 days after stroke onset
NIHSS (the National Institutes of Health Stroke Scale) score
At 18-24 hours after procedure, 24-74 hours after procedure, and 5-7 days after stroke onset and their changes from baseline.
Proportions of patients with a NIHSS score = 0 or 1, a NIHSS score = 0-2, a NIHSS score improvement ≥ 4 points, and a NIHSS score improvement ≥ 8 points.
At 18-24 hours after procedure, 24-74 hours after procedure, and 5-7 days after stroke onset.
+12 more secondary outcomes

Other Outcomes (1)

Other serious adverse events.
Within 90±14 days after stroke onset.

Study Arms (2)

Direct endovascular treatment group

SHAM COMPARATOR

Direct endovascular treatment (EVT) without intravenous thrombolysis (IVT)

Procedure: Endovascular treatment

Bridging treatment group

ACTIVE COMPARATOR

Intravenous thrombolysis (IVT) followed by endovascular treatment (EVT)

Procedure: Endovascular treatmentDrug: Intravenous thrombolysis (Alteplase)

Interventions

Endovascular treatmentPROCEDURE

It is the emergency surgical removal of emboli which are blocking blood circulation. The strategies that were used for endovascular treatment included stent retrievers, thromboaspiration, balloon angioplasty, stent deployment, intraarterial thrombolysis (with alteplase), or combinations of these approaches that were left to the discretion of the treating team.

Bridging treatment groupDirect endovascular treatment group

Intravenous thrombolysis (Alteplase)DRUG

Alteplase is used in the intravenous thrombolysis. It catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for clot breakdown.

Bridging treatment group

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

mRS score \> 2 before this stroke.
Any contraindication to IVT as per the 2019 AHA/ASA guidelines for early management of AIS:
\) 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.

Contact the study team to confirm eligibility.