high blood pressure hypertension
Conditions
Interventions
Placed percutaneously, the OneShotTM balloon catheter is advanced into the
renal artery using a routine femoral approach in a cardiac catheterization
laboratory setting. RF is applied with pre-progr
Sponsors
Maya Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Systolic blood pressure >= 160 mmHg despite treatment with a regimen of 3 or more anti-hypertensive medications taken at optimal dose amounts including a diuretic and that has been stable for two weeks prior to screening. 2. Age 18-85 years 3. Able to provide informed consent and comply with follow-up visits
Exclusion criteria
Exclusion criteria: 1. Diameter of left or right renal artery less then 4mm or greater then 7mm. 2. Length of treatable segment of renal artery less than 20mm. 3. Renal arterial abnormalities including severe renal artery stenosis, previous renal stenting or angioplasty. 4. End-stage renal disease requiring dialysis or renal transplant 5. eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. RDN Acute Safety, defined as overall rate of Serious Adverse Events (SAE*s) and adverse device effects at discharge: (a) SAE*s related to groin and vascular access complications, and (b) SAE*s related to renal artery injury 2. RDN Chronic Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months 3. RDN Effectiveness, defined as Office Systolic Blood Pressure (SBP) reduction >10 mmHg at 6 months compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Procedure time 2. Fluoroscopy time 3. Rate of Office SBP reduction >=10mmHg at 12, 24 and 36 months compared to baseline. | — |
Countries
Netherlands
Outcome results
None listed