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

NCT07051811 | Recruiting

• 1 other identifier: LPCTP-2021-004(CT)
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 18

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.

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in 24-hour average ambulatory systolic blood pressure (SBP) [at 6 months post-procedure]

  From baseline to 6 months

Secondary Outcomes (8)

• Change in Daytime/Nighttime Average Ambulatory Systolic Blood Pressure (SBP)

  1 Month, 2 Months, and 6 Months Post-Procedure

• Change in 24-Hour/Daytime/Nighttime Average Ambulatory Diastolic Blood Pressure (DBP)

  1 Month, 2 Months, and 6 Months Post-Procedure

• Change in 24-Hour Average Ambulatory Systolic Blood Pressure (SBP)

  1 Month and 2 Months Post-Procedure

• Change in Office Systolic Blood Pressure

  1 Month, 2 Months, and 6 Months Post-Procedure

• Change in Office Diastolic Blood Pressure

  1 Month, 2 Months, and 6 Months Post-Procedure

Study Arms (2)

Renal denervation (RDN) Group

EXPERIMENTAL

Receive standardized treatment with a minimum of two drugs and renal denervation treatments (RDN)

Procedure: Intravascular Ultrasound Ablation Therapy

Control Group

SHAM COMPARATOR

Receive standardized treatment with a minimum of two drugs and renal artery angiography only

Procedure: Renal Artery Angiography

Interventions

Intravascular Ultrasound Ablation Therapy PROCEDURE

The single-use intravascular ultrasound ablation catheter is used in conjunction with the ultrasound ablation device to remove renal sympathetic nerves. Standardized medication regimen.

Renal denervation (RDN) Group

Renal Artery Angiography PROCEDURE

Only undergo renal artery angiography. Standardized medication regimen.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lepu Medical Technology (Beijing) Co., Ltd.: lead

Study Sites (18)

Beijing Anzhen hospital , Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

NOT YET RECRUITING

Beijing Jishuitan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100035, China

RECRUITING

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

RECRUITING

The Second Affiliated Hospital Chongqing Medical University

Chongqing, Chongqing Municipality, 408599, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

NOT YET RECRUITING

The Second Hospital of Lanzhou University

Lanzhou, Gansu, 730030, China

RECRUITING

Shenzhen University General Hospital

Shenzhen, Guangdong, 518055, China

NOT YET RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Inner Mongolia People's Hospital

Hohhot, Neimenggu, 010017, China

RECRUITING

Yinchuan First People's Hospital

Yinchuan, Ningxia, 750001, China

RECRUITING

Affiliated Hospital of Qinghai University

Xining, Qinghai, 810001, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Zhejiang Hospital

Hangzhou, Zhejiang, 310030, China

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 4, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (18)