A Randomized Controlled Trial Evaluating the Efficacy and Safety of a Six-Channel Radiofrequency Ablation System Used in Renal Denervation for Treating Patients With Uncontrolled Hypertension and Chronic Kidney Disease

NAEnrolling by invitationINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

August 8, 2025

Primary Completion Date

December 30, 2026

Study Completion Date

September 30, 2030

Conditions
HypertensionCKD - Chronic Kidney Disease
Interventions
DEVICE

Six-channel RF Renal Denervation System

DSA-guided percutaneous renal sympathetic denervation using a six-channel RF renal denervation system-comprising the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the ultra-guiding radiofrequency denervation catheter (specification model: 25C6W127F115T)

PROCEDURE

Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation)

Sham procedure including femoral artery puncture and selective renal angiography; the six-channel radiofrequency generator is connected to a dummy load and produces activation sounds, but no energy is delivered. Minimum table time before sheath removal is 35 minutes.

Trial Locations (1)

100029

Beijing Anzhen Hospital, affiliated to Capital Medical University, Beijing

All Listed Sponsors
collaborator

Beijing Anzhen Hospital

OTHER

collaborator

Shanghai Zhongshan Hospital

OTHER

collaborator

Guangdong Provincial People's Hospital

OTHER

collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

collaborator

West China Hospital

OTHER

collaborator

Jiangxi Provincial People's Hopital

OTHER

collaborator

Navy General Hospital, Beijing

OTHER

collaborator

Qilu Hospital of Shandong University

OTHER

collaborator

Xijing Hospital

OTHER

collaborator

Fujian Provincial Hospital

OTHER

collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

collaborator

Henan Provincial People's Hospital

OTHER

collaborator

Hebei Provincial People's Hospital

UNKNOWN

collaborator

Anhui Provincial Hospital

OTHER_GOV

collaborator

The First Hospital of Jilin University

OTHER

collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

collaborator

Qianfoshan Hospital

OTHER

collaborator

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

collaborator

Mianyang Central Hospital

OTHER

collaborator

Xi'an International Medical Center Hospital

OTHER

lead

Shanghai Golden Leaf MedTec Co. Ltd

INDUSTRY