Balloon angioplasty or stent implantation vs medical therapy alone for watershed acute cerebral infarction due to anterior circulation intracranial atherosclerotic stenosis (BASWACI): a prospective, multi-center, open-label, randomized controlled trial in China

Background Watershed acute moderate-to-severe cerebral infarction caused by hypoperfusion in patients with anterior circulation intracranial atherosclerotic stenosis (ICAS) lacks effective early treatment options. Dual antiplatelet therapy (DAPT) (e.g., CHANCE, POINT trials) reduces stroke recurrence in mild stroke/transient ischemic attack (TIA) but does not improve functional prognosis. Patients with ICAS still have poor 90-day outcomes after intravenous thrombolysis, and watershed infarction specifically carries a poor prognosis. Retrospective data from our center suggest emergency balloon angioplasty/stent implantation may improve 90-day functional outcomes in this population, but no prospective evidence exists. Objectives To determine whether emergency balloon angioplasty or stent implantation combined with optimal medical therapy (OMT) achieves a better 90-day favorable functional outcome (modified Rankin Scale [mRS] ≤ 2) than OMT alone in patients with severe anterior circulation ICAS (70–99% stenosis) and moderate-to-severe watershed infarction (National Institutes of Health Stroke Scale [NIHSS] ≥ 6). Trial Registration Chinese Clinical Trial Registry (ChiCTR): ChiCTR2500108276