Actively Recruiting
To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension
Led by Lepu Medical Technology (Beijing) Co., Ltd. · Updated on 2025-07-04
213
Participants Needed
18
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Diagnosed with primary hypertension
- Stable use of at least two antihypertensive medications for at least 4 consecutive weeks, including an angiotensin II receptor blocker and a calcium channel blocker or a triple combination including a diuretic
- Office systolic blood pressure between 150 mmHg and less than 180 mmHg
- Office diastolic blood pressure of at least 90 mmHg
- 24-hour ambulatory systolic blood pressure between 135 mmHg and less than 170 mmHg
- Able to understand the study purpose, willing to participate voluntarily, and agree to follow clinical follow-up
You will not qualify if you...
- Main renal artery diameter less than 4 mm or length less than 20 mm
- Accessory renal artery diameter between 2 mm and less than 4 mm
- Renal artery stenosis greater than 50% in the main renal artery
- Presence of renal artery aneurysm, fibromuscular dysplasia, or severe calcification
- Presence of a renal artery stent
- Having only one kidney
- Estimated glomerular filtration rate less than 45 mL/min/1.73 m²
- Diagnosis of Type 1 Diabetes Mellitus
- Orthostatic hypotension
- Acute myocardial infarction, unstable angina, syncope, or stroke within 3 months before consent
- Suspected secondary hypertension
- Requires long-term oxygen support or mechanical ventilation (except nighttime support for sleep apnea)
- Previous renal artery denervation procedure
- Life expectancy less than 1 year
- Pregnancy, breastfeeding, or plans to become pregnant within 6 months (for females); males planning to conceive within 6 months
- Currently participating in another clinical trial without completion of primary endpoint
- Allergy to contrast agents
- Other reasons judged by the investigator to make the participant unsuitable, such as poor compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Beijing Anzhen hospital , Capital Medical University
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
2
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
3
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Not Yet Recruiting
4
Beijing Jishuitan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100035
Actively Recruiting
5
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 102218
Actively Recruiting
6
The Second Affiliated Hospital Chongqing Medical University
Chongqing, Chongqing Municipality, China, 408599
Actively Recruiting
7
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Not Yet Recruiting
8
The Second Hospital of Lanzhou University
Lanzhou, Gansu, China, 730030
Actively Recruiting
9
Shenzhen University General Hospital
Shenzhen, Guangdong, China, 518055
Not Yet Recruiting
10
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
11
Inner Mongolia People's Hospital
Hohhot, Neimenggu, China, 010017
Actively Recruiting
12
Yinchuan First People's Hospital
Yinchuan, Ningxia, China, 750001
Actively Recruiting
13
Affiliated Hospital of Qinghai University
Xining, Qinghai, China, 810001
Actively Recruiting
14
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
15
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
16
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710061
Actively Recruiting
17
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
18
Zhejiang Hospital
Hangzhou, Zhejiang, China, 310030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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