The Radiance II Pivotal study in Stage II Hypertension.
Research type
Research Study
Full title
The 'Radiance II' Pivotal Study. A study of the ReCor Medical Paradise System in Stage II Hypertension.
IRAS ID
252053
Contact name
Helen Reeve Stoffer
Contact email
Sponsor organisation
ReCor Medical Ltd,UK subsidiary of ReCor Medical Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 2 months, 22 days
Research summary
The Radiance II study will determine whether the Paradise System is able to effectively reduce blood pressure (BP) measured over 24 hrs (“ambulatory BP”) in patients with uncontrolled hypertension (high BP). The study is also designed to show that the Paradise System is safe for patients that are treated with it.
The ReCor Paradise Renal Denervation System (“Paradise System”) is a catheter-based (a thin, flexible plastic tube with a small plastic balloon on the end) system that delivers ultrasound energy to heat, treat and thus disable the nerves which are found in the tissue alongside the arterial blood vessel going to the kidney. The wall of the blood vessel is spared from damage by using a water-cooled balloon. The goal of treating these renal nerves is to reduce sympathetic over-activity with the resultant effect of reducing BP and preventing potential damage to other parts of the body that can be caused by high BP.
The study will run in approximately 50 hospitals in the UK and Europe and 50 hospitals in the USA. 225 patients who have been taken off their antihypertensive medication and who have BP that is higher than 135/85 mmHg when measured over 24hrs, will be enrolled and randomized. Eligible patients will be randomized to treatment or placebo (“sham procedure”) in a 2:1 ratio. All patients will undergo a hospital procedure (a diagnostic renal angiogram to look at the anatomy of the kidneys) but will be blinded as to whether they have received the treatment. Clinical staff conducting follow-ups will also be blinded.
The patients will attend clinic for screening and eligibility checks prior to the treatment or control procedure and then after hospital discharge they will also attend clinic for up to 9 follow up visits over a minimum duration of three years. During the study period, patients will have their BP monitored, both at clinic and at home. BP medications will also be carefully controlled and monitored.REC name
London - Central Research Ethics Committee
REC reference
18/LO/2045
Date of REC Opinion
25 Jan 2019
REC opinion
Further Information Favourable Opinion