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

Launched by LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people with primary hypertension, which is high blood pressure that isn’t caused by another health problem. The treatment uses a special single-use catheter that delivers ultrasound energy inside the blood vessels to help lower blood pressure. Researchers want to see if this treatment is safe and effective for people whose blood pressure remains high despite taking at least two different blood pressure medications.

To join the trial, participants need to be between 18 and 75 years old, have a history of high blood pressure, and have been taking a specific combination of blood pressure medicines steadily for at least a month. Their blood pressure must be above certain levels despite medication. If chosen, participants will undergo the ultrasound treatment and be monitored closely to check how well it works and to ensure it’s safe. Some people won’t be able to join, such as those with certain kidney artery problems, very poor kidney function, recent serious heart or brain events, or other specific health issues. The goal is to find a new way to help people control their blood pressure when medicines alone aren’t enough.

Gender

ALL

Eligibility criteria

• 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).