Dataset of a phase Ib clinical study: rapid regression of high-risk carotid hemorrhagic plaques with sonodynamic therapy

Carotid plaques with intraplaque hemorrhage (IPH) accelerate plaque progression and increase the risk of cerebrovascular events; however, safe and effective therapeutic strategies remain unavailable. We report the results of macrophage-targeted sonodynamic therapy (SDT) for treating patients with high-risk carotid plaques. Twelve participants with 24 plaques (15 with IPH and 9 without IPH) underwent a single SDT. Follow-up assessments were conducted at 1, 3, 6, and 9 months. The safety endpoints demonstrated no occurrence of serious adverse events. The primary endpoint demonstrated a significant decrease in maximum wall thickness (MaxWT) at 1 month post-SDT in all plaques, particularly IPH plaques. The secondary endpoint revealed a decreasing trend in IPH volume at 3 months post-SDT. The exploratory analysis revealed that SDT may suppress neovascularization, reduce inflammation, and promote dead cell clearance. Collectively, SDT safely and effectively promotes the rapid regression of carotid plaques with IPH. The study is registered on ClinicalTrials.gov (NCT03871725).