SMART-IC-Pilot Study

Starting soon · Not applicable

Conditions studied: Hypertensive Disease

In brief

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.

Key facts

Study ID

NCT07336433

Run by

SyMap Medical (Suzhou), Ltd.

People needed

15

Starts

2026-01-01

Expected to finish

2027-12-31

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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 -

Where it is running

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

Full record on ClinicalTrials.gov

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