Safety and Efficacy of Renal Denervation for Untreated Grade I Hypertension: a Pilot Study (STAR)

Safety and Efficacy of Six-Channel Radiofrequency Ablation System for Renal Denervation in Patients With Untreated Grade I Hypertension: a Pilot Study

Prospective, Multi-Center, Randomized, shame-Controlled, Uptake clinical trial to evaluate the efficacy and safety of the six-channel radio-frequency（RF) renal denervation system-comprising the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T)-for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Grade 1
• Intervention / Treatment: Device: Six-channel RF Renal Denervation System; Procedure: Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation)

Detailed Description

The six-channel RF renal denervation system, consisting of the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T), is designed and manufactured by Shanghai Golden Leaf MedTec Co., Ltd (BRATTEA) for renal artery RF denervation.

This Prospective, Multi-Center, Randomized, shame-controlled uptake clinical trial aims to evaluate the system's efficacy and safety for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines, and to provide clinical evidence supporting the expansion of indications. The trial will be conducted by the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Administration of Medical Device Registration and Filing, the Good Clinical Practice for Medical Devices, and other applicable requirements.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian-Zhong Xu, M.D. Ph.D; Phone Number: +86 21 64370045; Email: jianzhongxv@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female, aged 18 to 65 years inclusive
2. Hypertension duration longer than 3 months
3. Hypertensive subjects who have been stopped taking antihypertensive drugs continuously and stably for at least 4 weeks or who do not take antihypertensive drugs , with office systolic/diastolic blood pressure still ≥140/90 mmHg and <160/100 mmHg, and 24-hour ambulatory mean systolic /diastolic pressure ≥130/80 mmHg and <140/90 mmHg;
4. The subject or his/her legal representative fully understands the content of the informed consent form for this trial and voluntarily signs the written informed consent form.

Exclusion Criteria:

1. Pregnant or breastfeeding, or planning pregnancy during the study.
2. Renal artery anatomy unsuitable for ablation (e.g., ≥50% stenosis, renal artery aneurysm, malformation, renal artery diameter <3 mm, or treatable segment length <20 mm).
3. Subjects with a solitary kidney, prior renal transplantation, or requiring dialysis or eGFR<40mL/min/1.73m2。
4. Other secondary hypertension not related to kidney disease (such as primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid disease, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.).
5. Allergic to contrast agents.
6. Major surgery or trauma within 1 month before enrollment; acute coronary syndrome within 6 months; or planned surgery or cardiovascular interventional therapy within the next 6 months.
7. Orthostatic hypotension.
8. Type 1 diabetes mellitus.
9. History of bleeding diathesis and haematological disorders or coagulopathy
10. History of thromboembolic event within 6 months.
11. History of stroke or transient ischemic attack (TIA) within 6 months.
12. Severe peripheral arterial disease or unstable abdominal aortic aneurysm.
13. Severe valvular heart disease or anticipated need for surgical valve replacement during the study period. NYHA Class III/IV heart failure at screening or hospitalization for exacerbation of chronic heart failure within the past six months.
14. History of ventricular fibrillation, polymorphic ventricular tachycardia within six months, or prior implantation of an implantable cardioverter-defibrillator (ICD) or pacemaker.
15. Concomitant severe diseases that may interfere with study participation or affect survival, such as malignancy or AIDS.
16. Acute or severe systemic infection.
17. Other conditions deemed unsuitable for participation by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal denervation; Participants receive percutaneous renal sympathetic denervation under digital subtraction angiography (DSA) guidance using a six-channel radiofrequency generator(model 25D1G, software release SRG-V1) and ultra-guiding radiofrequency denervation catheter (model 25C6W127F115T) manufactured by Shanghai Golden Leaf MedTec Co., Ltd(BRATTEA). All participants receive a standardized antihypertensive regimen for ≥4 weeks before the procedure and thereafter per protocol. Follow-up visits occur at 7 days or before discharge, and at 1 and 3 months.	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)
Sham Comparator: Parallel control with sham operation; Participants undergo a sham procedure: femoral artery puncture and selective renal angiography under DSA guidance are performed. The RF generator is connected to a dummy load, and activation sounds are emitted, but no energy is delivered. Participants remain on the procedure table for at least 35 minutes before sheath removal. Background standardized antihypertensive therapy is provided for ≥4 weeks pre-procedure and continued per protocol. Follow-up visits occur at 7 days or before discharge, and at 1 and 3months.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 24-h ambulatory BP at 3 months post-procedure compared between the 2 groups.	the change in 24-h ambulatory systolic/diastolic BP at 3 months post-procedure compared between the 2 groups.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Daytime and Nighttime Ambulatory Systolic /diastolic Blood Pressure (ABPM)	24-hour mean systolic /diastolic BP measured by validated ambulatory BP monitoring;	Baseline to 3 Months
Percentage of Participants with 24-hour Ambulatory BP <130 /80 mmHg	24-hour mean BP measured by validated ambulatory BP monitoring;	Months 3 post-procedure
Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP)	measured by validated office blood pressure monitoring	Baseline to Months 3 post-procedure
Change from Baseline in Antihypertensive Medication Use	Change in the number of concurrently prescribed antihypertensive agents	Baseline to hospital discharge or Day 7 (whichever occurs first), and to Months 3 post-procedure
change from baseline in the time in target range of 24 hour ambulatory blood pressure	24-hour mean BP measured by validated ambulatory BP monitoring;	Months 3 post-procedure

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Guangdong Provincial People's Hospital; Shanghai Tongji Hospital, Tongji University School of Medicine; Shanghai Institute of Hypertension; Shanghai Golden Leaf MedTec Co. Ltd; Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: hypertension; renal denervation; grade I
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Hypertension; Lymphoma, Follicular
• Other Study ID Numbers: Ruijin2026-293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No