Single-use intravascular ultrasound (IVUS) ablation for primary hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Anzhen hospital , Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China 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 Second Hospital of Lanzhou University
  Lanzhou, Gansu, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.