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To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension

RecruitingNAAges 18 Years - 75 YearsAllLepu Medical Technology (Beijing) Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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. Accessory renal artery diameter ≥ 2 mm and \<4 mm. 3. Renal artery stenosis \>50% in the main renal artery. 4. Renal artery aneurysm, fibromuscular dysplasia, or severe calcification. 5. Presence of a renal artery stent. 6. Single kidney. 2. Estimated Glomerular Filtration Rate (eGFR) \<45 mL/min/1.73 m². 3. Diagnosis of Type 1 Diabetes Mellitus. 4. Orthostatic Hypotension. 5. Recent Vascular Events:Acute myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months prior to signing the informed consent form. 6. Suspected Secondary Hypertension. 7. Respiratory Support:a) Requirement for long-term oxygen support or mechanical ventilation (excluding nocturnal respiratory support for sleep apnea). 8. Prior Renal Artery Denervation Procedure. 9. Life Expectancy \<1 Year. 10. Pregnancy, Lactation, or Plans to Become Pregnant Within 6 Months (for Females); Males Planning to Conceive Within 6 Months. 11. Current Participation in Another Clinical Trial Without Completion of the Primary Endpoint. 12. Allergy to Contrast Agents. 13. Other Reasons Deemed by the Investigator to Make the Subject Unsuitable for Participation (e.g., Poor Compliance).
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What it tests

  • Intravascular Ultrasound Ablation Therapy
  • Renal Artery Angiography
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Where

18 sites
Beijing Anzhen hospital , Capital Medical University
Beijing, China
China-Japan Friendship Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Beijing Jishuitan Hospital Affiliated to Capital Medical University
Beijing, China
Beijing Tsinghua Changgung Hospital
Beijing, China
The Second Affiliated Hospital Chongqing Medical University
Chongqing, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
The Second Hospital of Lanzhou University
Lanzhou, China

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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