Basilar Artery Occlusion Chinese Endovascular Trial: Protocol for a prospective randomized controlled study

Area of Science:

• Neurology
• Interventional Neuroradiology
• Stroke Medicine

Background:

• Acute basilar artery occlusion is a severe stroke subtype with limited treatment options.
• Randomized trials are lacking to guide treatment decisions in the 6-24 hour window.

Purpose of the Study:

• To assess the safety and efficacy of mechanical thrombectomy compared to best medical therapy for acute basilar artery occlusion.

Main Methods:

• A prospective, multi-center, randomized controlled trial comparing mechanical thrombectomy (Solitaire device) plus best medical therapy (BMT) against BMT alone.
• 318 patients will be randomized 1:1, with an interim analysis after 212 patients.

Main Results:

• The primary outcome is the proportion of patients with modified Rankin Scale (mRS) score of 0-3 at 90 days.
• Secondary outcomes include early favorable response, dichotomized and ordinal mRS scores, infarct volume, and recanalization rates (mTICI 2b or 3).
• Safety outcomes include mortality, symptomatic intracranial hemorrhage, and procedure-related complications at 90 days.

Conclusions:

• This trial aims to provide crucial evidence on the effectiveness of mechanical thrombectomy for acute basilar artery occlusion in a specific time window.
• Findings will inform clinical practice regarding the optimal management strategy for this critical condition.