摘要
This study assessed the feasibility and safety of ultrasound renal denervation (uRDN) targeting both main and branch renal arteries to treat uncontrolled hypertension. A circumferential uRDN system was evaluated in a porcine model (n = 6) and a first-in-human study (n = 5). Endpoints included the incidence of device-related adverse events and changes in blood pressure. Preclinical studies revealed a favorable safety profile and >97% reduction in renal norepinephrine levels. In the human study, all procedures were technically successful without device-related adverse events. At 2 and 6 months, 24-hour ambulatory systolic/diastolic blood pressure decreased by 8.8 (95% CI: 0.98-16.62)/4.6 (95% CI: -1.83 to 11.03) mm Hg and 16 (95% CI: 1.18-30.82)/8 (95% CI: 0.76-15.24) mm Hg , respectively. These preliminary findings support the feasibility and safety of this circumferential uRDN approach for uncontrolled hypertension. (A Prospective Feasibility Trial Investigating the Use of Hantong Medical uRDN System in Patients With Uncontrolled Hypertension (Hammer HTN; ChiCTR2400093088).