Intravascular Ultrasound Ablation Therapy: The single-use intravascular ultrasound ablation catheter is used in conjunction with the ultrasound ablation device to remove renal sympathetic nerves.
Standardized medication regimen.
This is a prospective, multicenter, blinded, randomized controlled clinical trial designed to evaluate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Aged ≥18 years and ≤75 years, regardless of gender.
2. Documented history of primary hypertension.
3. Stable use of at least two antihypertensive medications for a minimum of 4 consecutive weeks prior to randomization, specifically requiring a combination of an angiotensin II receptor blocker (ARB) and a calcium channel blocker (CCB) or a triple combination of ARB/CCB plus a diuretic agent . After at least 4 consecutive weeks of screening, blood pressure must meet the following criteria:
1. Office systolic blood pressure (SBP) ≥150 mmHg and \<180 mmHg;
2. Office diastolic blood pressure (DBP) ≥90 mmHg;
3. 24-hour ambulatory systolic blood pressure ≥135 mmHg and \<170 mmHg.
4. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to comply with clinical follow-up.
Exclusion Criteria:
1. Unsuitable Renal Artery Anatomy for Treatment
1. Main renal artery diameter \<4 mm or length \<20 mm.
2. Accessory renal artery diameter ≥ 2 mm and \<4 mm.
3. Renal artery stenosis \>50% in the main renal artery.
4. Renal artery aneurysm, fibromuscular dysplasia, or severe calcification.
5. Presence of a renal artery stent.
6. Single kidney.
2. Estimated Glomerular Filtration Rate (eGFR) \<45 mL/min/1.73 m².
3. Diagnosis of Type 1 Diabetes Mellitus.
4. Orthostatic Hypotension.
5. Recent Vascular Events:Acute myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months prior to signing the informed consent form.
6. Suspected Secondary Hypertension.
7. Respiratory Support:a) Requirement for long-term oxygen support or mechanical ventilation (excluding nocturnal respiratory support for sleep apnea).
8. Prior Renal Artery Denervation Procedure.
9. Life Expectancy \<1 Year.
10. Pregnancy, Lactation, or Plans to Become Pregnant Within 6 Months (for Females); Males Planning to Conceive Within 6 Months.
11. Current Participation in Another Clinical Trial Without Completion of the Primary Endpoint.
12. Allergy to Contrast Agents.
13. Other Reasons Deemed by the Investigator to Make the Subject Unsuitable for Participation (e.g., Poor Compliance).
Primary outcome measure(s)
Change in 24-hour average ambulatory systolic blood pressure (SBP) [at 6 months post-procedure] — From baseline to 6 months
Trial sites (18)
Facility
City
Region
Status
Beijing Anzhen hospital , Capital Medical University
Beijing
Beijing Municipality
Recruiting
China-Japan Friendship Hospital
Beijing
Beijing Municipality
Recruiting
Peking University First Hospital
Beijing
Beijing Municipality
Not Yet Recruiting
Beijing Jishuitan Hospital Affiliated to Capital Medical University
Beijing
Beijing Municipality
Recruiting
Beijing Tsinghua Changgung Hospital
Beijing
Beijing Municipality
Recruiting
The Second Affiliated Hospital Chongqing Medical University
Chongqing
Chongqing Municipality
Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
Fujian
Not Yet Recruiting
The Second Hospital of Lanzhou University
Lanzhou
Gansu
Recruiting
Shenzhen University General Hospital
Shenzhen
Guangdong
Not Yet Recruiting
Henan Provincial People's Hospital
Zhengzhou
Henan
Recruiting
Inner Mongolia People's Hospital
Hohhot
Neimenggu
Recruiting
Yinchuan First People's Hospital
Yinchuan
Ningxia
Recruiting
Affiliated Hospital of Qinghai University
Xining
Qinghai
Recruiting
Qilu Hospital of Shandong University
Jinan
Shandong
Recruiting
Shanghai East Hospital
Shanghai
Shanghai Municipality
Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an
Shanxi
Recruiting
West China Hospital, Sichuan University
Chengdu
Sichuan
Recruiting
Zhejiang Hospital
Hangzhou
Zhejiang
Recruiting
More Lepu Medical Technology (Beijing) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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