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

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

⁃ 24-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.

Locations
Other Locations
China
Beijing Anzhen hospital , Capital Medical University
RECRUITING
Beijing
Beijing Jishuitan Hospital Affiliated to Capital Medical University
RECRUITING
Beijing
Beijing Tsinghua Changgung Hospital
RECRUITING
Beijing
China-Japan Friendship Hospital
RECRUITING
Beijing
Peking University First Hospital
NOT_YET_RECRUITING
Beijing
West China Hospital, Sichuan University
RECRUITING
Chengdu
The Second Affiliated Hospital Chongqing Medical University
RECRUITING
Chongqing
Zhejiang Hospital
RECRUITING
Hangzhou
Inner Mongolia People's Hospital
RECRUITING
Hohhot
Qilu Hospital of Shandong University
RECRUITING
Jinan
The Second Hospital of Lanzhou University
RECRUITING
Lanzhou
Shanghai East Hospital
RECRUITING
Shanghai
Shenzhen University General Hospital
NOT_YET_RECRUITING
Shenzhen
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi’an
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Affiliated Hospital of Qinghai University
RECRUITING
Xining
Yinchuan First People's Hospital
RECRUITING
Yinchuan
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Time Frame
Start Date: 2025-02-25
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 213
Treatments
Experimental: Renal denervation (RDN) Group
Receive standardized treatment with a minimum of two drugs and renal denervation treatments (RDN)
Sham_comparator: Control Group
Receive standardized treatment with a minimum of two drugs and renal artery angiography only
Related Therapeutic Areas
Sponsors
Leads: Lepu Medical Technology (Beijing) Co., Ltd.

This content was sourced from clinicaltrials.gov