[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618808":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":44,"collaborators":19,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":19,"enrollmentInfo":56,"targetDuration":19,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":19,"overallStatus":65,"whyStopped":19,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"SyMap Medical (Suzhou), Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"Mapping\u002FSelective Renal Denervation","EXPERIMENTAL",[12],"Device: The SymPioneer G2 Mapping\u002FSelective Renal Denervation Device and SyMapCath Catheter II",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","The SymPioneer G2 Mapping\u002FSelective Renal Denervation Device and SyMapCath Catheter II","Radiofrequency ablation of renal arterial sympathetic nerves",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Jie WANG, MD,PHD","CONTACT","+8613511604566","jay329329@yahoo.com",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"JingJing ZHANG, BM","+8613914047970","jjzhang@symapmedical.com",[31],{"facility":32,"status":19,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":19},"Shanghai Zhongshan Hospital, Fudan University","Shanghai","Shanghai Municipality","200032","China","CN",{"type":39,"coordinates":40},"Point",[41,42],121.45806,31.22222,{"lat":42,"lon":41},{"type":45,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100618808","smart-ic-pilot-study-100618808",false,"NCT07336433","SMART-IC-Pilot Study","EFS Study of the Renal Nerve Mapping\u002FSelective Renal Denervation (msRDN) System in the Absence of Antihypertensive Medications: A Prospective, Multicentre, Single-Arm Exploratory Trial","SMART-IC-Pilot","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Documented essential hypertension\n3. Resistant or drug-intolerant hypertension, particularly in patients requiring medication reduction\n4. Office BP ≥ 140\u002F90 mmHg and \\\u003C 180\u002F110 mmHg while on a stable regimen of 1-2 antihypertensive medications for ≥ 4 weeks before consent\n5. Documented daytime ASBP ≥ 135 mmHg and \\\u003C 170 mmHg after 2-week washout\n6. Able and willing to comply with all study procedures and follow-up visit\n\nExclusion Criteria:\n\n1.Renal artery anatomy on either side, unsuitable for treatment:\n\n1. Main renal artery diameter \\\u003C 4 mm or \\> 8 mm\n2. Main renal artery length \\\u003C 25 mm\n3. Single functioning kidney\n4. Presence of abnormal kidney (or secreting adrenal) tumors\n5. Renal artery with aneurysm\n6. Pre-existing renal stent or history of renal artery angioplasty\n7. Prior renal denervation procedure\n8. Renal artery stenosis ≥ 50% 2.Active infection within 7 days of procedure 3.Iliac\u002Ffemoral artery stenosis precluding msRDN catheter insertion 4.Type I diabetes mellitus 5.eGFR \\\u003C45 mL\u002Fmin\u002F1.73 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 \\\u003C 1 year at the discretion of the Investigator 14.Known drug\u002Falcohol dependence or inability to comply with study protocol Pregnant, breastfeeding or intend to become pregnant within 12 months -","ALL","18 Years",{"count":57,"type":58},15,"ESTIMATED","INTERVENTIONAL",[61],"NA","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.",[64],"Hypertensive Disease","NOT_YET_RECRUITING","2026-01-12",{"date":68,"type":69},"2026-01-13","ACTUAL",{"date":71,"type":58},"2026-01-01",{"date":73,"type":58},"2027-12-31",{"name":5,"class":6},1]