NCT07336433Not yet recruiting
SMART-IC-Pilot Study
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
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 18 Dec 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- SyMap Medical (Suzhou), Ltd.
- Diseases
- High blood pressure
- NCT number
- NCT07336433
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 1 Jan 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior renal denervation procedure
Other illness
- Pre-existing renal stent or history of renal artery angioplasty
Lab values
- 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 -
Other
- 1.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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Zhongshan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.