The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
NCT ID: NCT03614260
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
225 participants
INTERVENTIONAL
2018-12-14
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Renal Denervation
Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)
Paradise Renal Denervation System
Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
Sham Control
Renal Angiogram
Renal Angiogram
Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.
Interventions
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Paradise Renal Denervation System
Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
Renal Angiogram
Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Known, uncorrected causes of secondary hypertension other than sleep apnea
* Type I diabetes mellitus or uncontrolled Type II diabetes
* eGFR of \<40
* Brachial circumference ≥ 42 cm
* Any history of cerebrovascular event or severe cardiovascular event, or history of stable or unstable angina within 12 months prior to consent
* Repeat (\>1) hospitalization for hypertensive crisis within 12 months prior to screening period, or any hospitalization for hypertensive crisis within 3 months prior to screening period
* Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
* Primary pulmonary hypertension
* Night shift workers
* Pregnant, nursing or planning to become pregnant
18 Years
75 Years
ALL
No
Sponsors
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ReCor Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ajay Kirtane, MD, SM
Role: PRINCIPAL_INVESTIGATOR
Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation
Prof. Michel Azizi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou
Locations
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Cardiology PC
Birmingham, Alabama, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Stamford Hospital
Stamford, Connecticut, United States
MedStar Washington
Washington D.C., District of Columbia, United States
The Cardiac and Vascular Institute
Gainesville, Florida, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
Ochsner Heart and Vascular Institute
New Orleans, Louisiana, United States
The Brigham and Women's Hospital
Boston, Massachusetts, United States
Munson Medical Center
Traverse City, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Saint Luke's Health System
Kansas City, Missouri, United States
Renown Regional Medical Center
Reno, Nevada, United States
Deborah Heart & Lung Center
Browns Mills, New Jersey, United States
Hackensack University
Hackensack, New Jersey, United States
Columbia University Medical Center/NYPH
New York, New York, United States
Northwell Health Inc.
New York, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The University of Tennessee Health Science Center
Memphis, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Utah
Salt Lake City, Utah, United States
Swedish Medical Center
Seattle, Washington, United States
Centre Hospitalier Universitaire Saint-Pierre
Brussels, , Belgium
Hôpital Saint André
Bordeaux, , France
CHRU de Lille
Lille, , France
Hôpital Européen Georges-Pompidou (HEGP)
Paris, , France
University Clinic Erlangen
Erlangen, , Germany
University Clinic of Saarland - Homburg
Homburg, , Germany
Klinikum Karlsruhe GmbH
Karlsruhe, , Germany
Klinikum Konstanz
Konstanz, , Germany
Herzzentrum Leipzig GmbH
Leipzig, , Germany
Sana Kliniken Lübeck GmbH
Lübeck, , Germany
University Hospital Galway
Galway, , Ireland
Erasmus Medical Center
Rotterdam, , Netherlands
Hôpitaux Universitaires Genève
Geneva, , Switzerland
The Cardiothoracic Centre Basildon University Hospital
Basildon, Essex, United Kingdom
University Hospitals Dorset NHS Foundation Trust
Bournemouth, , United Kingdom
Kent & Canterbury Hospital
Canterbury, , United Kingdom
University Hospital Wales
Cardiff, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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References
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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.
Azizi M, Sharp ASP, Fisher NDL, Weber MA, Lobo MD, Daemen J, Lurz P, Mahfoud F, Schmieder RE, Basile J, Bloch MJ, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Claude L, Augustin DA, McClure CK, Kirtane AJ; RADIANCE Investigators. Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program. Circulation. 2024 Mar 5;149(10):747-759. doi: 10.1161/CIRCULATIONAHA.123.066941. Epub 2023 Oct 26.
Kirtane AJ, Sharp ASP, Mahfoud F, Fisher NDL, Schmieder RE, Daemen J, Lobo MD, Lurz P, Basile J, Bloch MJ, Weber MA, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Sapoval M, Barman NC, Claude L, Augustin D, Thackeray L, Mullin CM, Azizi M; RADIANCE Investigators and Collaborators. Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials. JAMA Cardiol. 2023 May 1;8(5):464-473. doi: 10.1001/jamacardio.2023.0338.
Other Identifiers
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RADIANCE II Study
Identifier Type: -
Identifier Source: org_study_id
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