Single-use intravascular ultrasound (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

This will test whether a single-use intravascular ultrasound ablation device can safely lower blood pressure in adults with primary (essential) hypertension who are on a standardized ARB/CCB-based medication regimen.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 213 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Lepu Medical Technology (Beijing) Co., Ltd. (Industry-sponsored)
• Locations: 18 sites (Beijing, Beijing Municipality and 17 other locations)
• Trial ID: NCT07051811 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, randomized controlled trial enrolling adults with primary hypertension who remain hypertensive on a standardized ARB/CCB or triple ARB/CCB/diuretic regimen. After a 4-week run-in with standardized medications and ambulatory blood pressure confirmation, eligible subjects are randomized 2:1 to receive intravascular ultrasound (IVUS) renal artery ablation or renal artery angiography alone. The treatment arm undergoes IVUS ablation while the control arm has angiography only, and both groups continue the standardized medication regimen with follow-up for at least six months. Safety outcomes and changes in office and ambulatory blood pressure will be tracked to determine whether the device adds blood-pressure lowering beyond medication.

Who should consider this trial

Good fit: Adults aged 18–75 with primary (essential) hypertension whose office and 24-hour ambulatory blood pressures meet the trial thresholds despite at least two antihypertensive drugs including an ARB/CCB combination or ARB/CCB plus diuretic are ideal candidates.

Not a fit: Patients with unsuitable renal artery anatomy, secondary hypertension, very high uncontrolled blood pressure outside the trial ranges, or those unable to attend Beijing study sites are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If effective, the procedure could provide an additional minimally invasive option to lower blood pressure and reduce long-term cardiovascular risk for patients not fully controlled on medication.

How similar studies have performed: Other catheter-based renal denervation studies using radiofrequency or ultrasound have produced modest blood-pressure reductions in some randomized trials, but overall results have been variable and the approach remains under active study.

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. 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).

Where this trial is running

Beijing, Beijing Municipality and 17 other locations

• Beijing Anzhen hospital , Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking University First Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Jishuitan Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The Second Affiliated Hospital Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Not_yet_recruiting)
• The Second Hospital of Lanzhou University — Lanzhou, Gansu, China (Recruiting)
• Shenzhen University General Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
• Inner Mongolia People's Hospital — Hohhot, Neimenggu, China (Recruiting)
• Yinchuan First People's Hospital — Yinchuan, Ningxia, China (Recruiting)
• Affiliated Hospital of Qinghai University — Xining, Qinghai, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
• Zhejiang Hospital — Hangzhou, Zhejiang, China (Recruiting)

Conditions Essential Hypertension