SMART-IC-Pilot Study
ConditionHypertensive Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSyMap Medical (Suzhou), Ltd.
About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov