About this 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.
Eligibility criteria
Qualifiers
Clinical symptoms or imaging findings suggestive of acute posterior circulation ischemic stroke.
Basilar artery occlusion confirmed by CTA, MRA, or DSA.
Posterior circulation ASPECTS <7 on CT, CTA source images, or MRI-DWI.
Age 18 to 80 years.
Disqualifiers
Pre-stroke modified Rankin Scale score ≥3.
Pregnancy or lactation.
Known allergy to contrast agents or nickel-titanium alloy.
Current participation in another clinical trial.
Trial design
Treatments tested in this trial
- Endovascular Therapy
- Best Medical Management
Treatment groups
Locations
Sponsors and collaborators
The First Affiliated Hospital of University of Science and Technology of China
Lead sponsor
Dalian Municipal Central Hospital
Collaborator
Linyi People's Hospital
Collaborator
Fujian Zhangzhou hospital
Collaborator
Shanghai Minhang District Central Hospital
Collaborator