Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN（FIM）

Launched by SHENZHEN PULSECARE MEDICAL TECHNOLOGY CO., LTD. · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new procedure called renal endovascular nerve elimination to help treat essential hypertension, which is high blood pressure that isn’t caused by other medical conditions. The study will take place in China and aims to enroll 6 participants who are between 18 and 65 years old. To be eligible, individuals must have been taking two or more blood pressure medications consistently for at least four weeks, and their blood pressure readings must fall within specific ranges. Participants will need to sign a consent form to join.

During the trial, participants will undergo a series of evaluations, including blood pressure checks before and after the procedure, as well as at one, two, three, and six months afterward. It's important that participants continue their usual blood pressure medications without changes for six months after the procedure, unless their blood pressure becomes too high or too low. This trial aims to determine if this new treatment is safe and effective for helping people manage their blood pressure better.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Males or females aged 18 years old or above and 65 years old or below; Patients with essential hypertension; Patients who have been stably taking 2 or more antihypertensive drugs at conventional doses continuously for at least 4 weeks before enrollment, and whose blood pressure meets the following conditions: (1) The systolic blood pressure measured in the outpatient clinic is ≥150 mmHg and ≤180 mmHg, and the diastolic blood pressure measured in the outpatient clinic is ≥90 mmHg; (2) The systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM) is between 135 mmHg and 170 mmHg; The course of hypertension is more than 6 months; The diameter of the renal artery evaluated by renal artery CTA is ≥3 mm and the length is ≥20 mm; The patient or his/her legal representative signs a written informed consent form approved by the ethics committee before screening;
• Exclusion Criteria:
• • Complicated with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (defined as plasma Hb1Ac ≥ 10.0%); Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m²; Previous implantation of an implantable cardioverter-defibrillator (ICD) or a pacemaker; History of myocardial infarction, syncope, intracerebral hemorrhage or cerebral infarction within 6 months before signing the informed consent form; Severe valvular heart stenosis; Any factors that may interfere with blood pressure measurement under any circumstances (for example, the patient has severe peripheral vascular disease, abdominal aortic aneurysm, hemorrhagic disorders such as thrombocytopenia, hemophilia, severe anemia); Patients with sleep apnea syndrome; Females who are pregnant or breastfeeding, or those who have a plan to conceive within the next year; Other serious organic diseases with an expected lifespan of less than 12 months; Participation in other clinical trials before screening and not yet completed;
• Preoperative exclusion criteria based on CTA imaging:
• • a. Visual inspection shows that the diameter stenosis of the renal artery on either side \> 50% or there is a renal artery aneurysm on either side; b. Previous history of renal artery interventional treatment; Other situations that the investigator deems unsuitable for enrollment.