To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension
NCT07051811 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 213
Last updated 2025-07-04
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.
Conditions
- Essential Hypertension
Interventions
- 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.
Sponsors & Collaborators
-
Lepu Medical Technology (Beijing) Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-25
- Primary Completion
- 2027-12-31
- Completion
- 2029-12-31
Countries
- China
Study Locations
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