Hypertension
Conditions
Brief summary
A single center, self-controlled pilot study on safety and efficacy of renal denervation in treatment of hypertension.
Interventions
DEVICERadio frequency renal denervation system (Golden Leaf GL-06E15A)
Sponsors
Shanghai Golden Leaf MedTec Co. Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Ages of 18 to 75, male or female; * Main renal artery, with or without accessary renal arteries, with length * 20mm; * Patients who have not taken any anti-hypertensive drugs or have been off drugs for at least 2 weeks, with mean SBP ≥150mmHg and * 180mmHg based on at least 3 office blood pressure measurements, or ASBP≥135mmHg and ≤170mmHg based on 24 hr blood pressure monitoring; * Agrees to take part in the trial and signs the written, informed consent.
Exclusion criteria
* Renal artery abnormalities that are inappropriate for the procedure; * Pregnant or plan to become pregnant; * History of orthostatic hypotension; * Type I diabetes; * Estimated GFR\<40mL/min/1.73m2; * Only one kidney or prior kidney transplantation; * Bleeding tendency or other coagulation related diseases; * Acute or severe systemic infection; * Prior renal artery interventional procedures or prior RDN treatment; * History of stroke or TIA; * Malignant tumor or end-stage illnesses; * Secondary hypertension; * Acute coronary events within 2 weeks; * Other conditions that deem unsuitable for the procedure, in the opinions of investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood pressure | 6 months |
Countries
China
Contacts
Primary ContactGengshan Ma, MD
Outcome results
None listed