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

Status: Active, not recruiting
Location: See all (59) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: No
View:

• Previously or currently prescribed antihypertensive therapy

• Average office BP ≥ 140/90 mmHg <180/120 mmHg while stable for at least 4 weeks on 0-2 classes of antihypertensive medication

• Documented daytime ABP ≥ 135/85 mmHg and < 170/105 mmHg after 4-week washout/run-in period

Locations
United States
Alabama
Cardiology PC
Birmingham
Arkansas
Central Arkansas Veterans Healthcare System
Little Rock
California
Cedars Sinai Medical Center
Los Angeles
Connecticut
Bridgeport Hospital
Bridgeport
Stamford Hospital
Stamford
Washington, D.c.
MedStar Washington
Washington
Florida
The Cardiac and Vascular Institute
Gainesville
Georgia
Emory University Hospital Midtown
Atlanta
Illinois
Northwestern University
Chicago
Southern Illinois University
Springfield
Indiana
Franciscan Health
Indianapolis
Louisiana
Ochsner Heart and Vascular Institute
New Orleans
Massachusetts
Massachusetts General Hospital
Boston
The Brigham and Women's Hospital
Boston
Michigan
Sparrow Clinical Research Institute
Lansing
Munson Medical Center
Traverse City
Minnesota
Minneapolis Heart Institute Foundation
Minneapolis
Missouri
Saint Luke's Health System
Kansas City
Mississippi
Cardiology Associates of North Mississippi
Tupelo
North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill
New Jersey
Deborah Heart & Lung Center
Browns Mills
Hackensack University
Hackensack
Nevada
Renown Regional Medical Center
Reno
New York
Columbia University Medical Center/NYPH
New York
Northwell Health Inc.
New York
Stony Brook University
Stony Brook
Ohio
Cleveland Clinic
Cleveland
Pennsylvania
University of Pennsylvania Health System
Philadelphia
University of Pittsburgh Medical Center
Pittsburgh
South Carolina
Medical University of South Carolina
Charleston
Tennessee
The University of Tennessee Health Science Center
Memphis
Vanderbilt University
Nashville
Utah
University of Utah
Salt Lake City
Washington
Swedish Medical Center
Seattle
Other Locations
Belgium
Centre Hospitalier Universitaire Saint-Pierre
Brussels
Hôpital Civil Marie Curie
Charleroi
ZOL Genk Campus Sint-Jan
Genk
France
Hôpital Saint André
Bordeaux
CHRU de Lille
Lille
Hôpital Européen Georges-Pompidou (HEGP)
Paris
Germany
University Clinic Erlangen
Erlangen
University Clinic of Saarland - Homburg
Homburg
Klinikum Karlsruhe GmbH
Karlsruhe
UKSH Kiel
Kiel
Klinikum Konstanz
Konstanz
Herzzentrum Leipzig GmbH
Leipzig
Sana Kliniken Lübeck GmbH
Lübeck
Ireland
University Hospital Galway
Galway
Netherlands
Hartlong Centrum
Alkmaar
Erasmus Medical Center
Rotterdam
Switzerland
Hôpitaux Universitaires Genève
Geneva
United Kingdom
The Cardiothoracic Centre Basildon University Hospital
Basildon
Heartlands Hospital Birmingham
Birmingham
University Hospitals Dorset NHS Foundation Trust
Bournemouth
Kent & Canterbury Hospital
Canterbury
University Hospital Wales
Cardiff
The Queen Elizabeth University Hospital
Glasgow
St Bartholomew's Hospital
London
Freeman Hospital
Newcastle Upon Tyne
Time Frame
Start Date: December 14, 2018
Estimated Completion Date: July 2027
Participants
Target number of participants: 225
Treatments
Experimental: Renal Denervation
Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)
Sham Comparator: Sham Control
Renal Angiogram
Authors
Anthony Adams, Devireddy Chandanreddy, Nicholas Robinsonn, Sudha G. Iyer, Ajay Jain, James Jenkins, Siddhartha Rao, Amar Krishnaswamy, John Schindler, Luis Juncos, Matheen Khuddus, Robert Fishman, John Pacella, Ajay J Kirtane, Florian Rader, Keith Benzuly, Jason Lindsey, Brian Bigelow, Paul Huang, Farrell Mendelsohn, David Hsi, Indranil Dasgupta, Kausik Umanath, Atul Chugh, Michael Bloch, Uzoma Ibebuogu, Joel Cohn, David Landers, Yale Wang, Thomas Todoran, Raghava Gollapudi, Venkatesh Nadar, John Flack, Kintur Sanghvi, Brian Go, Pete Fong, Joseph Garasic, Rajender Singh, Nelson Bernardo, John Reilly, Barry Bertolet, Hans-Otto Peels, Johannes Peels, Dirk Boswijk, Neelan Das, Sanneke de Boer, Christian Delcour, Pascal Lefebvre, Shunji Nishio, Martin Hausberg, Julie Kolwelter, Pascal Delsart, Anthony Mathur, Olaf Oldenburg, Felix Mahfoud, Prof. Michel Azizi, Julia Gänsbacher, Derk Frank, Udo Desch, Timothy Ellam, Juliane Dederer, Roland Schmieder, Kristina Striepe, François Pontana, Romain Boulestreau, Lukas Hafer, Ram Kasthuri, Dennis Kannenkeril, Philipp Lurz, Lucas Lauder, Axel Schmid, Christian Binner, Alan Bagnall, Samer Fawaz, Antoine Fayol, Panteleimon Papadopoulos, Atul Pathak, Antoine Cremer, Hervé Trillaud, Mounir Bouzgarrou, Guillaume Ledieu, Jeremy W. Sayer, Sebastian Ewen, Justin Hennicaux, David Beckett, Rachid Briki, Clare Bent, Patrick Rasoamanana, Ralph Jackson, Lena Griesinger, Richard Watkin, Matthias Lutz, Andrew Sharp, Constantin Kuehl, Dominic Millenaar, Joachim Weil, Karl Bihlmaier, Marc Sapoval, Benjamin Longere, Nicholas Robinson, Terry Levy, Philippe Gosse, Nikolaos Dagkonakis, Michael Böhm, Christian Ott, Sebastian Keil, Phillip Muench, Andrea Llano, Vivek Kodoth, Rene-Alexander Starick, Patrick Fischer, Anne Blanchard, Marvin Lafeber, Tolga Agdirliogu, Franck Hamann, Yi-Ming Yang, Marine Livrozet, Rick Stouffer, Ann-Kathrin Berger, Doulton Tim, Stephen Williams, Florian Fahr, Nicolas Cavez, Peter Reimer, Paul-Edouard Allard, Jan van Ramshorst, Mariëlle Duffels, Johannes Rotta detto Loria, Kushan Galav, Diederik van Wijk, John Bisognano, Firaz Al-Janabi, Naeif Almagal, Danilo Obradovic, Admir Dedic, Richard Anderson, Jo Abraham, Juan F. Iglesias, Panagiotis Xaplanteris, Sophie Degrauwe, Saarraaken Kulenthiran, Koen Ameloot, Melvin Lafeber, Chandan Devireddy, Myles McKittrick, Linsay McCallum, Stefanie Lip, Jean-Sebastien Hulot, Julien Doublet, Sandosh Padmanabhan, Mattia Lunardi, Jan Hein Cornel, Krishnaraj Rathod, Georg Ehret, Karl-Philipp Rommel, Daniel Jones, Matheen Khuddu, David Verhaert, Kevin Rogers, Faisal Sharif, Karl Fengler, Quentin De Hemptinne, Joost Daemen, Debbie Cohen, Manish Saxena, Naomi Fisher, David Collier, Johanne Frank, Jorie Versmissen, Anand Prasad, Bert Ferdinande, Benjamin Feldmann
Related Therapeutic Areas
Sponsors
Leads: ReCor Medical, Inc.

This content was sourced from clinicaltrials.gov

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