NCT07051811

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 213 (estimated)
• Sponsor: Lepu Medical Technology (Beijing) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial adopts a prospective, multicenter, randomized controlled design to validate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension. Subjects who signed the informed consent form will enter the screening phase and undergo a run-in period for 4-week of standardized medication regimen. Specifically, their current antihypertensive treatment will be uniformly replaced with a combination of an angiotensin II receptor blocker (ARB) and calcium channel blocker (CCB) (Valsartan/Amlodipine 80:5 mg) or a triple combination of ARB/CCB (Valsartan/Amlodipine 80:5 mg) plus a diuretic (Hydrochlorothiazide 12.5mg) . If the subject's office systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg during the run-in period, the investigator may adjust the medication and restart a run-in period of ≥28 days. Blood pressure will be re-evaluated, and subjects failed to meet the inclusion criteria after adjustment will be excluded. Subjects meeting the inclusion criteria and not violating exclusion criteria will be randomized in a 2:1 ratio to either the treatment group or the control group. The treatment group will undergo intravascular ultrasound ablation therapy, while the control group will only undergo renal artery angiography. Both groups will maintain the standardized medication regimen for 6 months post-procedure (if a subject's office SBP exceeds 180 mmHg or drops below 110 mmHg in three consecutive measurements spaced 1 hour apart, the investigator may adjust the medication and record their blood pressure before the adjustment). The primary efficacy endpoint is the change in 24-hour average ambulatory systolic blood pressure at 6 months post-procedure. Results will be analyzed using a superiority testing hypothesis to demonstrate that the treatment group achieves significantly greater reduction in 24-hour mean ambulatory systolic blood pressure compared to the control group at 6-month follow-up. During follow-up, office blood pressure, 24-hour ambulatory blood pressure, medication usage, safety events, and adverse events will be recorded for both groups.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	Renal Artery Angiography	Only undergo renal artery angiography. Standardized medication regimen.

Timeline

• Start date: 2025-02-25
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2025-07-04
• Last updated: 2025-07-04

Locations

18 sites across 1 country: China