Endovascular Therapy for Acute Basilar Artery Occlusion With Large Ischemic Core

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of University of Science and Technology of China

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

256 Participants
are divided into 2 treatment groups

Locations

This trial has no 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