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

Recruiting now · Not applicable

Conditions studied: Essential Hypertension

In brief

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.

Key facts

Study ID

NCT07051811

Run by

Lepu Medical Technology (Beijing) Co., Ltd.

People needed

213

Starts

2025-02-25

Expected to finish

2029-12-31

Last updated by the study team

2025-07-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged ≥18 years and ≤75 years, regardless of gender.
• Documented history of primary hypertension.
• 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:
• Office systolic blood pressure (SBP) ≥150 mmHg and <180 mmHg;
• Office diastolic blood pressure (DBP) ≥90 mmHg;
• 24-hour ambulatory systolic blood pressure ≥135 mmHg and <170 mmHg.
• 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.

You may not qualify if…

• Unsuitable Renal Artery Anatomy for Treatment
• Main renal artery diameter <4 mm or length <20 mm.
• Accessory renal artery diameter ≥ 2 mm and <4 mm.
• Renal artery stenosis >50% in the main renal artery.
• Renal artery aneurysm, fibromuscular dysplasia, or severe calcification.
• Presence of a renal artery stent.
• Single kidney.
• Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m².
• Diagnosis of Type 1 Diabetes Mellitus.
• Orthostatic Hypotension.
• Recent Vascular Events:Acute myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months prior to signing the informed consent form.
• Suspected Secondary Hypertension.
• Respiratory Support:a) Requirement for long-term oxygen support or mechanical ventilation (excluding nocturnal respiratory support for sleep apnea).
• Prior Renal Artery Denervation Procedure.
• Life Expectancy <1 Year.
• Pregnancy, Lactation, or Plans to Become Pregnant Within 6 Months (for Females); Males Planning to Conceive Within 6 Months.
• Current Participation in Another Clinical Trial Without Completion of the Primary Endpoint.
• Allergy to Contrast Agents.
• Other Reasons Deemed by the Investigator to Make the Subject Unsuitable for Participation (e.g., Poor Compliance).

Where it is running

• Zhejiang Hospital — Hangzhou, Zhejiang, China (enrolling)
• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (enrolling)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (enrolling)
• Beijing Anzhen hospital , Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Beijing Jishuitan Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China (enrolling)
• The Second Affiliated Hospital Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
• The Second Hospital of Lanzhou University — Lanzhou, Gansu, China (enrolling)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (enrolling)
• Inner Mongolia People's Hospital — Hohhot, Neimenggu, China (enrolling)
• Yinchuan First People's Hospital — Yinchuan, Ningxia, China (enrolling)
• Affiliated Hospital of Qinghai University — Xining, Qinghai, China (enrolling)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)
• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Peking University First Hospital — Beijing, Beijing Municipality, China
• Shenzhen University General Hospital — Shenzhen, Guangdong, China
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.