ICAS - Intracranial Atherosclerosis Clinical Trial
Official title:
IntraCranial Angiography-derived Fraction Flow-guided Percutaneous Transluminal Angioplasty and Stenting Versus Medical Therapy (ICAS-MT)
A multicenter, open-label, blinded-endpoint, prospective, randomized controlled clinical trial with an "all comers" design.
The main objective of this study is to investigate the impact of angiography-derived fractional flow (Angio-FF) on diagnostic and therapeutic decision-making in patients with symptomatic intracranial atherosclerotic stenosis (sICAS). The study aims to evaluate whether stenting plus medical therapy, compared to medical therapy alone, can benefit patients selected through Angio-FF screening. For Group A, patients with significant stenosis and hemodynamic impairment identified through Angio-FF (≤0.7) screening are expected to have a higher risk. The patients will be enrolled in RCT trial, with a planned enrollment of 336 subjects. For Group B, patients with significant stenosis but without hemodynamic impairment identified through Angio-FF (>0.7) screening will be included in the registry cohort, with a planned enrollment of 200 subjects. ;