Safety and Efficacy of Renal Denervation for Untreated Grade I Hypertension: a Pilot Study (STAR)
23 juni 2026 uppdaterad av: Xu jianzhong, Ruijin Hospital
Safety and Efficacy of Six-Channel Radiofrequency Ablation System for Renal Denervation in Patients With Untreated Grade I Hypertension: a Pilot Study
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.
Studieöversikt
Status
Har inte rekryterat ännu
Detaljerad beskrivning
The six-channel RF renal denervation system, consisting of the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T), is designed and manufactured by Shanghai Golden Leaf MedTec Co., Ltd (BRATTEA) for renal artery RF denervation.
This Prospective, Multi-Center, Randomized, shame-controlled uptake clinical trial aims to evaluate the system's efficacy and safety for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines, and to provide clinical evidence supporting the expansion of indications. The trial will be conducted by the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Administration of Medical Device Registration and Filing, the Good Clinical Practice for Medical Devices, and other applicable requirements.
Studietyp
Interventionell
Inskrivning (Beräknad)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jian-Zhong Xu, M.D. Ph.D
- Telefonnummer: +86 21 64370045
- E-post: jianzhongxv@outlook.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Male or female, aged 18 to 65 years inclusive
- Hypertension duration longer than 3 months
- 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/diastolic blood pressure still ≥140/90 mmHg and <160/100 mmHg, and 24-hour ambulatory mean systolic /diastolic pressure ≥130/80 mmHg and <140/90 mmHg;
- The subject or his/her legal representative fully understands the content of the informed consent form for this trial and voluntarily signs the written informed consent form.
Exclusion Criteria:
- Pregnant or breastfeeding, or planning pregnancy during the study.
- Renal artery anatomy unsuitable for ablation (e.g., ≥50% stenosis, renal artery aneurysm, malformation, renal artery diameter <3 mm, or treatable segment length <20 mm).
- Subjects with a solitary kidney, prior renal transplantation, or requiring dialysis or eGFR<40mL/min/1.73m2。
- Other secondary hypertension not related to kidney disease (such as primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid disease, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.).
- Allergic to contrast agents.
- 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.
- Orthostatic hypotension.
- Type 1 diabetes mellitus.
- History of bleeding diathesis and haematological disorders or coagulopathy
- History of thromboembolic event within 6 months.
- History of stroke or transient ischemic attack (TIA) within 6 months.
- Severe peripheral arterial disease or unstable abdominal aortic aneurysm.
- Severe valvular heart disease or anticipated need for surgical valve replacement during the study period. NYHA Class III/IV heart failure at screening or hospitalization for exacerbation of chronic heart failure within the past six months.
- History of ventricular fibrillation, polymorphic ventricular tachycardia within six months, or prior implantation of an implantable cardioverter-defibrillator (ICD) or pacemaker.
- Concomitant severe diseases that may interfere with study participation or affect survival, such as malignancy or AIDS.
- Acute or severe systemic infection.
- Other conditions deemed unsuitable for participation by the investigator.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Renal denervation
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.
|
DSA-guidad perkutan njurens sympatisk denervering med hjälp av en sex-kanals RF-renal denerveringssystem-comprising the Six-Channel Radiofrequency Generator (Specification Model: 25D1G, Software Release Version: SRG-V1) och Ultrakanal Radiofrequency Denervation Catheter (Specification Model: 25C6W12777777777777777
|
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Sham Comparator: Parallel control with sham operation
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.
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Skamförfarande inklusive femoral artärpunkter och selektiv njurangiografi; Sexkanalens radiofrekvensgenerator är ansluten till en dummybelastning och producerar aktiveringsljud, men ingen energi levereras.
Minsta bordstid innan mantelavlägsnande är 35 minuter.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in 24-h ambulatory BP at 3 months post-procedure compared between the 2 groups.
Tidsram: 3 months
|
the change in 24-h ambulatory systolic/diastolic BP at 3 months post-procedure compared between the 2 groups.
|
3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from Baseline in Daytime and Nighttime Ambulatory Systolic /diastolic Blood Pressure (ABPM)
Tidsram: Baseline to 3 Months
|
24-hour mean systolic /diastolic BP measured by validated ambulatory BP monitoring;
|
Baseline to 3 Months
|
|
Percentage of Participants with 24-hour Ambulatory BP <130 /80 mmHg
Tidsram: Months 3 post-procedure
|
24-hour mean BP measured by validated ambulatory BP monitoring;
|
Months 3 post-procedure
|
|
Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP)
Tidsram: Baseline to Months 3 post-procedure
|
measured by validated office blood pressure monitoring
|
Baseline to Months 3 post-procedure
|
|
Change from Baseline in Antihypertensive Medication Use
Tidsram: Baseline to hospital discharge or Day 7 (whichever occurs first), and to Months 3 post-procedure
|
Change in the number of concurrently prescribed antihypertensive agents
|
Baseline to hospital discharge or Day 7 (whichever occurs first), and to Months 3 post-procedure
|
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change from baseline in the time in target range of 24 hour ambulatory blood pressure
Tidsram: Months 3 post-procedure
|
24-hour mean BP measured by validated ambulatory BP monitoring;
|
Months 3 post-procedure
|
Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
30 december 2027
Avslutad studie (Beräknad)
30 december 2027
Studieregistreringsdatum
Först inskickad
25 maj 2026
Först inskickad som uppfyllde QC-kriterierna
23 juni 2026
Första postat (Faktisk)
24 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Ruijin2026-293
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
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Nej
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produkt tillverkad i och exporterad från U.S.A.
Nej
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