To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension
This study tests a new catheter-based ultrasound treatment designed to help lower blood pressure in people with essential hypertension. The procedure uses sound waves delivered through a thin catheter to treat blood vessels, and researchers will monitor its safety and effectiveness compared to standard care.
Key Objective: The trial is testing whether ultrasound ablation can effectively lower blood pressure as a potential alternative treatment for primary hypertension.
Who to Consider: People with essential hypertension who may be interested in exploring a minimally invasive catheter-based treatment option should consider enrolling.
Trial Parameters
Brief 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 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.