SMART-IC-Pilot Study (SMART-IC-Pilot)

EFS Study of the Renal Nerve Mapping/Selective Renal Denervation (msRDN) System in the Absence of Antihypertensive Medications: A Prospective, Multicentre, Single-Arm Exploratory Trial

This small-scale, proof-of-concept pilot study aims to obtain preliminary evidence of msRDN procedural safety, feasibility, and short-term efficacy in patients with hypertension without medication therapy, to adequately plan an appropriate pivotal study.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertensive Disease
• Intervention / Treatment: Device: The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II

Detailed Description

This is a prospective, multicenter, single-arm, exploratory study enrolling 15 subjects across approximately four sites with a 6-month follow-up period. Subjects are patients with uncontrolled hypertension who receive 1-2 antihypertensive medications and have completed a minimum two-week medication wash-out period prior to enrollment, or patients with uncontrolled hypertension without medication therapy.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JingJing ZHANG, BM; Phone Number: +8613914047970; Email: jjzhang@symapmedical.com
• Study Contact Backup: Name: Jie WANG, MD,PHD; Phone Number: +8613511604566; Email: jay329329@yahoo.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Shanghai Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Documented essential hypertension
3. Resistant or drug-intolerant hypertension, particularly in patients requiring medication reduction
4. Office BP ≥ 140/90 mmHg and < 180/110 mmHg while on a stable regimen of 1-2 antihypertensive medications for ≥ 4 weeks before consent
5. Documented daytime ASBP ≥ 135 mmHg and < 170 mmHg after 2-week washout
6. Able and willing to comply with all study procedures and follow-up visit

Exclusion Criteria:

1.Renal artery anatomy on either side, unsuitable for treatment:

1. Main renal artery diameter < 4 mm or > 8 mm
2. Main renal artery length < 25 mm
3. Single functioning kidney
4. Presence of abnormal kidney (or secreting adrenal) tumors
5. Renal artery with aneurysm
6. Pre-existing renal stent or history of renal artery angioplasty
7. Prior renal denervation procedure
8. Renal artery stenosis ≥ 50% 2.Active infection within 7 days of procedure 3.Iliac/femoral artery stenosis precluding msRDN catheter insertion 4.Type I diabetes mellitus 5.eGFR <45 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula) 6.Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) 7.Any history of severe cardiovascular event (myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV) 8.Documented confirmed episode(s) of stable or unstable angina 9.Documented repeat (> 1) hospitalization for hypertensive crisis within the prior 12 months 10.Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea 11.Primary pulmonary hypertension 12.Documented contraindication or allergy to contrast medium not amenable to treatment 13.Limited life expectancy of < 1 year at the discretion of the Investigator 14.Known drug/alcohol dependence or inability to comply with study protocol Pregnant, breastfeeding or intend to become pregnant within 12 months -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mapping/Selective Renal Denervation	Device: The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II; Radiofrequency ablation of renal arterial sympathetic nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in daytime ASBP	mean change in average daytime ASBP from baseline to 2 months post-procedure.	From baseline to 2 months after RDN

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in office SBP	Change in Office Systolic BP from baseline to 1 month,2 months,3 months and 6 months post-procedure;	From baseline to 1, 2, 3 and 6 months after RDN
Change in average 24-hr/Night-time Ambulatory BP(Systolic and Diastolic)	change in Average 24-hr/Night-time Ambulatory BP(Systolic and Diastolic) from baseline to 2 months and daytime ambulatory Diastolic BP from baseline to 2 months post procedure	From baseline to 2 months after RDN (for both 24-hr and night-time SBP/DBP); From baseline to 2 months after RDN (for daytime DBP)
Change in 24-hr Ambulatory BP	Change in 24-hr Ambulatory BP from baseline to 6 months post-procedure	From baseline to 6 months after RDN
Change in anti-hypertensive Drugs	Change in anti-hypertensive Drugs form baseline to 1 month、2 months、3 months and 6 months post-procedure;	From baseline to 1, 2, 3 and 6 months after RDN

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of the renal interventional therapy procedure	The renal denervation catheter can be engaged to the correct position in renal artery, successfully performed renal nerve ablation procedure and has no related complications such as renal arterial perforation;	Immediately after the procedure and at 7 days post-procedure (or prior to discharge, whichever occurs first
Success rate of clinical treatment	Based on succeed performance of renal interventional therapy procedure , there are no the procedure-related SAE, such as acute infection and renal dysfunction. 7 days after the procedure or at the time the patient is discharged from hospital	Immediately after the procedure and at 7 days post-procedure (or prior to discharge, whichever occurs first
All-cause mortality		From baseline to 1, 2, 3 and 6 months after RDN
Severe renal dysfunction (eGFR<15mL/min/m2 or renal function replacement therapy needed)		From baseline to 6 months after RDN
Rate of new-onset renal artery stenosis assessed (stenosis > 70% )		From baseline to 2 and 6 months after RDN
AEs, SAEs and severe cardio-cerebrovascular events		From baseline to1,3 and 6 months after RDN

Collaborators and Investigators

• Sponsor: SyMap Medical (Suzhou), Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: SMART-IC-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No