The objective of this study is to show that the safety and efficacy of renal denervation using DENEX, are superior to those of control group for the patients with hypertension on no or 1 to 3 antihypertensive medications.
DENEX system developed by Handok Kalos Medical Inc. is a renal denervation system to efficiently block the sympathetic nerve of the kidney with minimal invasive procedure. It was developed to block the sympathetic nerves distributed in blood vessel wall by delivering high frequency energy to the renal artery for the purpose of treating hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Renal Denervation: DENEX system
Changes in average daytime ambulatory systolic blood pressure at 3 months
Changes in average daytime ambulatory systolic blood pressure from baseline at 3 months after the procedure
Time frame: from baseline at 3 months after the procedure
Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months
Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure from baseline at 3, 6 and 12 months after the procedure
Time frame: from baseline at 3, 6 and 12 months after the procedure
Changes in average office systolic blood pressure and diastolic blood pressure at 1, 3, 6 and 12 months
Changes in average office systolic blood pressure and diastolic blood pressure from baseline at 1,3, 6 and 12 months after the procedure
Time frame: from baseline at 1, 3, 6 and 12 months after the procedure
Changes in average daytime and nighttime ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months
Changes in average daytime and nighttime ambulatory systolic blood pressure and diastolic blood pressure from baseline at 3, 6 and 12 months after the procedure
Time frame: from baseline at 3, 6 and 12 months after the procedure
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