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Clinical Trials in China / NCT07051811
Recruiting Not applicable

To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension

NCT07051811 · tracked via the Priya Life Science China tracker
Sponsor
Lepu Medical Technology (Beijing) Co., Ltd.
Phase
Not applicable
Started
2025-02-25
Last updated
2025-07-04

Condition(s) studied

Essential Hypertension

Investigational drug(s) / intervention(s)

Intravascular Ultrasound Ablation TherapyRenal Artery Angiography

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.

Renal Artery Angiography: Only undergo renal artery angiography. Standardized medication regimen.

Study summary

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)

Trial sites (18)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT07051811 on ClinicalTrials.gov ↗ ← All trials in China