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Be Part of Research - Trial Details - The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

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

Not Recruiting

Open to: ALL

Age: 18.0 - 75.0

Medical Conditions

Hypertension
Cardiovascular Diseases
Vascular Diseases


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2018 Dec 2022

Publications

"Azizi M, Saxena M, Wang Y, Jenkins JS, Devireddy C, Rader F, Fisher NDL, Schmieder RE, Mahfoud F, Lindsey J, Sanghvi K, Todoran TM, Pacella J, Flack J, Daemen J, Sharp ASP, Lurz P, Bloch MJ, Weber MA, Lobo MD, Basile J, Claude L, Reeve-Stoffer H, McClure CK, Kirtane AJ; RADIANCE II Investigators and Collaborators. Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial. JAMA. 2023 Feb 28;329(8):651-661. doi: 10.1001/jama.2023.0713. Erratum In: JAMA. 2023 Jun 13;329(22):1989. doi: 10.1001/jama.2023.8136."; "36853250"

INTERVENTIONAL

Intervention Type : DEVICE
Intervention Description : Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Intervention Arm Group : Renal Denervation;

Intervention Type : PROCEDURE
Intervention Description : Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.

Intervention Arm Group : Sham Control;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Kent & Canterbury Hospital
    Canterbury
    CT1 3NG
  • University Hospital Wales
    Cardiff
  • The Cardiothoracic Centre Basildon University Hospital
    Basildon
    Essex
    SS16 5NL
  • University Hospitals Dorset NHS Foundation Trust
    Bournemouth
    BH7 7DW
  • St Bartholomew's Hospital
    London
    EC1A 7BE
  • Freeman Hospital
    Newcastle Upon Tyne
    NE7 7DN


The study is sponsored by ReCor Medical, Inc.




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Read full details for Trial ID: NCT03614260
Last updated 01 April 2025

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