The 'Radiance II' Pivotal Study. A study of the ReCor Medical Paradise System in Stage II Hypertension.
Trial objectiveThe 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.
StatusOpen to recruitment
CI/PIDr Manish Saxena (PI)
SponsorReCor Medical Inc
FunderReCor Medical Inc
Study summaryThe ReCor Medical Paradise® Renal Denervation System (Paradise System) is a catheter-based system that delivers ultrasound energy to thermally ablate and disrupt the renal efferent and afferent sympathetic nerves while sparing the renal arterial wall. The goal of renal nerve ablation is to achieve a reduction in sympathetic over-activity with the resultant effect of reducing systemic arterial blood pressure (BP), and mitigating resultant end-organ damage.
Sample size and duration225; approximately 5 years
Enquiries Dr Manish Saxena: email@example.comArmida Balawon: firstname.lastname@example.org