RecruitingNot ApplicableNCT07051811

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

Sponsor

Lepu Medical Technology (Beijing) Co., Ltd.

Enrollment

213 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

Essential Hypertension

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

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;
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.

Exclusion Criteria19

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).

Interventions

PROCEDUREIntravascular 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.

PROCEDURERenal Artery Angiography

Only undergo renal artery angiography. Standardized medication regimen.