The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
225
Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.
Incidence of Major Adverse Events (MAE)
Time frame: From baseline to 30 days post-procedure
Change in average daytime ambulatory systolic BP
Time frame: From baseline to 2 months post-procedure
Change in average 24-hr ambulatory systolic BP
Time frame: From baseline to 2 months post-procedure
Change in average office systolic BP
Time frame: From baseline to 2 months post-procedure
Change in average home systolic BP
Time frame: From baseline to 2 months post-procedure
Change in average daytime ambulatory diastolic BP
Time frame: From baseline to 2 months post-procedure
Change in average 24-hr ambulatory diastolic BP
Time frame: From baseline to 2 months post-procedure
Change in average office diastolic BP
Time frame: From baseline to 2 months post-procedure
Change in average home diastolic BP
Time frame: From baseline to 2 months post-procedure
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