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
1 other identifier
interventional
15
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedFirst Posted
Study publicly available on registry
January 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
January 13, 2026
January 1, 2026
1.5 years
December 18, 2025
January 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change in office SBP
From baseline to 1, 2, 3 and 6 months after RDN
Change in average 24-hr/Night-time Ambulatory BP(Systolic and Diastolic)
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
From baseline to 6 months after RDN
Change in anti-hypertensive Drugs
From baseline to 1, 2, 3 and 6 months after RDN
Other Outcomes (6)
Success rate of the renal interventional therapy procedure
Immediately after the procedure and at 7 days post-procedure (or prior to discharge, whichever occurs first
Success rate of clinical treatment
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
- +3 more other outcomes
Study Arms (1)
Mapping/Selective Renal Denervation
EXPERIMENTALMapping/Selective Renal Denervation
Interventions
Radiofrequency ablation of renal arterial sympathetic nerves
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Documented essential hypertension
- Resistant or drug-intolerant hypertension, particularly in patients requiring medication reduction
- Office BP ≥ 140/90 mmHg and \< 180/110 mmHg while on a stable regimen of 1-2 antihypertensive medications for ≥ 4 weeks before consent
- Documented daytime ASBP ≥ 135 mmHg and \< 170 mmHg after 2-week washout
- Able and willing to comply with all study procedures and follow-up visit
You may not qualify if:
- Renal artery anatomy on either side, unsuitable for treatment:
- Main renal artery diameter \< 4 mm or \> 8 mm
- Main renal artery length \< 25 mm
- Single functioning kidney
- Presence of abnormal kidney (or secreting adrenal) tumors
- Renal artery with aneurysm
- Pre-existing renal stent or history of renal artery angioplasty
- Prior renal denervation procedure
- 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 -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2025
First Posted
January 13, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
January 13, 2026
Record last verified: 2026-01