Clinical Trial

The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

Study acronym: RADIANCE-II
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 49 amendments
This ClinicalTrials.gov record has been amended 49 times since 2018-07-30; most recent amendment 2025-04-01.
Status change: Recruiting → Active, Not Recruiting 2022-03-28
Status change: Active, Not Recruiting → Recruiting 2020-06-16
Status change: Recruiting → Active, Not Recruiting 2020-04-06
Status change: Not Yet Recruiting → Recruiting 2019-01-11
Trial Details
NCT Number NCT03614260
Lead Sponsor ReCor Medical, Inc.
Conditions Hypertension, Vascular Diseases, Cardiovascular Diseases
Enrollment 225 participants
Start Date 2018-12-14
Primary Completion 2022-12-21 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2025-04-04