To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension (NCT07051811) | Clinical Trial Compass
RecruitingNot Applicable
To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension
China213 participantsStarted 2025-02-25
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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:
✓. 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
✕. 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.
What they're measuring
1
Change in 24-hour average ambulatory systolic blood pressure (SBP) [at 6 months post-procedure]
Timeframe: From baseline to 6 months
Trial details
NCT IDNCT07051811
SponsorLepu Medical Technology (Beijing) Co., Ltd.