RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System)
Incidence of Adverse Events
Time frame: From baseline to 60 months
Change in average daytime ambulatory systolic BP
Time frame: From baseline to 2 months post procedure
Change in average 24-hr/night-time ambulatory systolic BP
Time frame: From baseline to 2 months post procedure
Change in average daytime/24-hr/night-time ambulatory systolic BP
Time frame: From Baseline to Months 6 and 12 post procedure
Change in average office systolic/diastolic BP
Time frame: From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure
Change in average home systolic/diastolic BP
Time frame: From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure
Change in average 24-hr/night-time ambulatory diastolic BP
Time frame: From baseline to Months 2, 6, and 12 post procedure
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