SMART-IC-Pilot Study

NCT ID: NCT07336433

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-12-31

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.

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.

Conditions

Hypertensive Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mapping/Selective Renal Denervation

Mapping/Selective Renal Denervation

Group Type: EXPERIMENTAL

The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II

Intervention Type: DEVICE

Radiofrequency ablation of renal arterial sympathetic nerves

Interventions

The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II

Radiofrequency ablation of renal arterial sympathetic nerves

Intervention Type: DEVICE

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SyMap Medical (Suzhou), Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jie WANG, MD,PHD

Role: CONTACT

jay329329@yahoo.com

+8613511604566

JingJing ZHANG, BM

Role: CONTACT

jjzhang@symapmedical.com

+8613914047970

Other Identifiers

SMART-IC-2025

Identifier Type: -

Identifier Source: org_study_id