[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644150":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":26,"responsibleParty":38,"collaborators":42,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":79,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":26},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Renal denervation","EXPERIMENTAL","Participants receive percutaneous renal sympathetic denervation under digital subtraction angiography (DSA) guidance using a six-channel radiofrequency generator(model 25D1G, software release SRG-V1) and ultra-guiding radiofrequency denervation catheter (model 25C6W127F115T) manufactured by Shanghai Golden Leaf MedTec Co., Ltd(BRATTEA). All participants receive a standardized antihypertensive regimen for ≥4 weeks before the procedure and thereafter per protocol. Follow-up visits occur at 7 days or before discharge, and at 1 and 3 months.",[13],"Device: Six-channel RF Renal Denervation System",{"label":15,"type":16,"description":17,"interventionNames":18},"Parallel control with sham operation","SHAM_COMPARATOR","Participants undergo a sham procedure: femoral artery puncture and selective renal angiography under DSA guidance are performed. The RF generator is connected to a dummy load, and activation sounds are emitted, but no energy is delivered. Participants remain on the procedure table for at least 35 minutes before sheath removal. Background standardized antihypertensive therapy is provided for ≥4 weeks pre-procedure and continued per protocol. Follow-up visits occur at 7 days or before discharge, and at 1 and 3months.",[19],"Procedure: Parallel controln with sham operation(there is no rade and\u002For generic name,It is a blank control sham operation)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Six-channel RF Renal Denervation System","DSA-guided percutaneous renal sympathetic denervation using a six-channel RF renal denervation system-comprising the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the ultra-guiding radiofrequency denervation catheter (specification model: 25C6W127F115T)",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Parallel controln with sham operation(there is no rade and\u002For generic name,It is a blank control sham operation)","Sham procedure including femoral artery puncture and selective renal angiography; the six-channel radiofrequency generator is connected to a dummy load and produces activation sounds, but no energy is delivered. Minimum table time before sheath removal is 35 minutes.",[15],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Jian-Zhong Xu, M.D. Ph.D","CONTACT","+86 21 64370045","jianzhongxv@outlook.com",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Xu jianzhong","Vice Chief of department of Hypertension",[43,45,47,49,51],{"name":44,"class":6},"Guangdong Provincial People's Hospital",{"name":46,"class":6},"Shanghai Tongji Hospital, Tongji University School of Medicine",{"name":48,"class":6},"Shandong First Medical University",{"name":50,"class":6},"Shanghai Institute of Hypertension",{"name":52,"class":53},"Shanghai Golden Leaf MedTec Co. Ltd","INDUSTRY","100644150","safety-and-efficacy-of-renal-denervation-for-untreated-grade-i-hypertension-a-pilot-study-100644150",false,"NCT07664787","Safety and Efficacy of Renal Denervation for Untreated Grade I Hypertension: a Pilot Study","Safety and Efficacy of Six-Channel Radiofrequency Ablation System for Renal Denervation in Patients With Untreated Grade I Hypertension: a Pilot Study","STAR","Inclusion Criteria:\n\n1. Male or female, aged 18 to 65 years inclusive\n2. Hypertension duration longer than 3 months\n3. Hypertensive subjects who have been stopped taking antihypertensive drugs continuously and stably for at least 4 weeks or who do not take antihypertensive drugs , with office systolic\u002Fdiastolic blood pressure still ≥140\u002F90 mmHg and \\\u003C160\u002F100 mmHg, and 24-hour ambulatory mean systolic \u002Fdiastolic pressure ≥130\u002F80 mmHg and \\\u003C140\u002F90 mmHg;\n4. The subject or his\u002Fher legal representative fully understands the content of the informed consent form for this trial and voluntarily signs the written informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding, or planning pregnancy during the study.\n2. Renal artery anatomy unsuitable for ablation (e.g., ≥50% stenosis, renal artery aneurysm, malformation, renal artery diameter \\\u003C3 mm, or treatable segment length \\\u003C20 mm).\n3. Subjects with a solitary kidney, prior renal transplantation, or requiring dialysis or eGFR\\\u003C40mL\u002Fmin\u002F1.73m2。\n4. Other secondary hypertension not related to kidney disease (such as primary aldosteronism, pheochromocytoma\u002Fparaganglioma, Cushing's syndrome, thyroid disease, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.).\n5. Allergic to contrast agents.\n6. Major surgery or trauma within 1 month before enrollment; acute coronary syndrome within 6 months; or planned surgery or cardiovascular interventional therapy within the next 6 months.\n7. Orthostatic hypotension.\n8. Type 1 diabetes mellitus.\n9. History of bleeding diathesis and haematological disorders or coagulopathy\n10. History of thromboembolic event within 6 months.\n11. History of stroke or transient ischemic attack (TIA) within 6 months.\n12. Severe peripheral arterial disease or unstable abdominal aortic aneurysm.\n13. Severe valvular heart disease or anticipated need for surgical valve replacement during the study period. NYHA Class III\u002FIV heart failure at screening or hospitalization for exacerbation of chronic heart failure within the past six months.\n14. History of ventricular fibrillation, polymorphic ventricular tachycardia within six months, or prior implantation of an implantable cardioverter-defibrillator (ICD) or pacemaker.\n15. Concomitant severe diseases that may interfere with study participation or affect survival, such as malignancy or AIDS.\n16. Acute or severe systemic infection.\n17. Other conditions deemed unsuitable for participation by the investigator.","ALL","18 Years","65 Years",{"count":66,"type":67},20,"ESTIMATED","INTERVENTIONAL",[70],"NA","Prospective, Multi-Center, Randomized, shame-Controlled, Uptake clinical trial to evaluate the efficacy and safety of the six-channel radio-frequency（RF) renal denervation system-comprising the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T)-for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines.",[73,74],"Hypertension","Grade 1",[76,77,78],"hypertension","renal denervation","grade I","NOT_YET_RECRUITING","2026-06-23",{"date":82,"type":83},"2026-06-24","ACTUAL",{"date":85,"type":67},"2026-07-01",{"date":87,"type":67},"2027-12-30",{"name":5,"class":6}]