Status:
RECRUITING
Safety and Efficacy of Modulated Ultrasound Renal Denervation for HTN（FIM）
Lead Sponsor:
Shenzhen Pulsecare Medical Technology Co., Ltd.
Conditions:
Essential Hypertension
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study is a prospective and exploratory clinical study, enrolling patients with essential hypertension. This study is planned to be conducted in 2 research institutions in China, and a total of 6 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06877234
Start Date
August 8 2024
End Date
March 1 2026
Last Update
June 19 2025
Active Locations (1)
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1
the Second Affiliated Hospital of Sun Yat-sen University （Sun Yat-sen Memorial Hospital）
Guangzhou, Guangdong, China, 510120