RecruitingNot ApplicableNCT07051811

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

A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of a Single-Use Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation System in the Treatment of Primary Hypertension


Sponsor

Lepu Medical Technology (Beijing) Co., Ltd.

Enrollment

213 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a catheter-based procedure called renal denervation — which uses ultrasound energy to disrupt nerves near the kidney arteries — to help lower blood pressure in people with treatment-resistant high blood pressure (primary hypertension). A special imaging tool called IVUS (intravascular ultrasound) guides the procedure. **You may be eligible if:** - You are between 18 and 75 years old - You have confirmed primary high blood pressure - You have been on at least 2 blood pressure medications (including specific drug combinations) for at least 4 weeks, and your blood pressure remains above 150/90 in the office and 135 mmHg over 24 hours - Your kidney arteries have suitable anatomy for the procedure - You are able to understand and comply with the study requirements **You may NOT be eligible if:** - You have had a heart attack, stroke, or unstable angina within the past 3 months - You have type 1 diabetes, low standing blood pressure (orthostatic hypotension), or suspected secondary hypertension - Your kidneys are significantly damaged (eGFR below 45) - You have already had a renal denervation procedure - You are pregnant or planning to become pregnant within 6 months - You have a life expectancy of less than 1 year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIntravascular 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.

PROCEDURERenal Artery Angiography

Only undergo renal artery angiography. Standardized medication regimen.


Locations(18)

Beijing Anzhen hospital , Capital Medical University

Beijing, Beijing Municipality, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Beijing Jishuitan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

The Second Affiliated Hospital Chongqing Medical University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

The Second Hospital of Lanzhou University

Lanzhou, Gansu, China

Shenzhen University General Hospital

Shenzhen, Guangdong, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Inner Mongolia People's Hospital

Hohhot, Neimenggu, China

Yinchuan First People's Hospital

Yinchuan, Ningxia, China

Affiliated Hospital of Qinghai University

Xining, Qinghai, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Zhejiang Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07051811


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