Kidney nerve catheter treatment for high blood pressure without medication
Tests a catheter treatment of kidney nerves in adults with high blood pressure.
Plain-language title generated from the registry record
Registry title: SMART-IC-Pilot Study
Key facts
- Where
- Shanghai, ChinaSee the site
Where in China
- Shanghai Zhongshan Hospital, Fudan UniversityShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- SyMap Medical (Suzhou), Ltd.
- Trial code
- NCT07336433
- Record updated
- 13 January 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Prior renal denervation procedure; Pre-existing renal stent or history of renal artery angioplasty; 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 -; 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.