- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03614260
The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension (RADIANCE-II)
June 20, 2023 updated by: ReCor Medical, Inc.
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
225
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brussels, Belgium, 1000
- Centre Hospitalier Universitaire Saint-Pierre
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Bordeaux, France, 33000
- Hôpital Saint André
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Lille, France, 59000
- CHRU de Lille
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Paris, France, 75015
- Hôpital Européen Georges-Pompidou (HEGP)
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Erlangen, Germany, D-91054
- University Clinic Erlangen
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Homburg, Germany, D-66421
- University Clinic of Saarland - Homburg
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Karlsruhe, Germany, 76133
- Klinikum Karlsruhe GmbH
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Konstanz, Germany, D-78464
- Klinikum Konstanz
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Leipzig, Germany, D-04289
- Herzzentrum Leipzig GmbH
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Lübeck, Germany, D-23560
- Sana Kliniken Lübeck GmbH
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Galway, Ireland, H91 YR71
- University Hospital Galway
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Rotterdam, Netherlands, 3015 GD
- Erasmus Medical Center
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Geneva, Switzerland, 1211
- Hôpitaux Universitaires Genève
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Bournemouth, United Kingdom, BH7 7DW
- University Hospitals Dorset NHS Foundation Trust
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Canterbury, United Kingdom, CT1 3NG
- Kent & Canterbury Hospital
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Cardiff, United Kingdom
- University Hospital Wales
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London, United Kingdom, EC1A 7BE
- St Bartholomew's Hospital
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Newcastle Upon Tyne, United Kingdom, NE7 7DN
- Freeman Hospital
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Essex
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Basildon, Essex, United Kingdom, SS16 5NL
- The Cardiothoracic Centre Basildon University Hospital
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Alabama
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Birmingham, Alabama, United States, 35211
- Cardiology PC
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California
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Los Angeles, California, United States, 940048
- Cedars Sinai Medical Center
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Connecticut
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Bridgeport, Connecticut, United States, 06610
- Bridgeport Hospital
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Stamford, Connecticut, United States, 06904
- Stamford Hospital
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District of Columbia
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Washington, District of Columbia, United States, 20010
- MedStar Washington
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Florida
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Gainesville, Florida, United States, 32605
- The Cardiac and Vascular Institute
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Georgia
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Atlanta, Georgia, United States, 30308
- Emory University Hospital Midtown
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Springfield, Illinois, United States, 62794
- Southern Illinois University
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Heart and Vascular Institute
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Massachusetts
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Boston, Massachusetts, United States, 02120
- The Brigham and Women's Hospital
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Michigan
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Traverse City, Michigan, United States, 49684
- Munson Medical Center
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- Minneapolis Heart Institute Foundation
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Missouri
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Kansas City, Missouri, United States, 64111
- Saint Luke's Health System
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Nevada
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Reno, Nevada, United States, 89502
- Renown Regional Medical Center
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New Jersey
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Browns Mills, New Jersey, United States, 08015
- Deborah Heart & Lung Center
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Hackensack, New Jersey, United States, 07601
- Hackensack University
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center/NYPH
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New York, New York, United States, 10075
- Northwell Health Inc.
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- The University of North Carolina at Chapel Hill
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Health System
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, United States, 38163
- The University of Tennessee Health Science Center
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Nashville, Tennessee, United States, 37232
- Vanderbilt University
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Utah
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Salt Lake City, Utah, United States, 84132
- University of Utah
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Washington
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Seattle, Washington, United States, 98122
- Swedish Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Lacks appropriate renal artery anatomy for treatment
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Renal Denervation
Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)
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Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
Other Names:
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Sham Comparator: Sham Control
Renal Angiogram
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Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Major Adverse Events (MAE)
Time Frame: From baseline to 30 days post-procedure
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From baseline to 30 days post-procedure
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Change in average daytime ambulatory systolic BP
Time Frame: From baseline to 2 months post-procedure
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From baseline to 2 months post-procedure
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in average 24-hr ambulatory systolic BP
Time Frame: From baseline to 2 months post-procedure
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From baseline to 2 months post-procedure
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Change in average office systolic BP
Time Frame: From baseline to 2 months post-procedure
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From baseline to 2 months post-procedure
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Change in average home systolic BP
Time Frame: From baseline to 2 months post-procedure
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From baseline to 2 months post-procedure
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Change in average daytime ambulatory diastolic BP
Time Frame: From baseline to 2 months post-procedure
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From baseline to 2 months post-procedure
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Change in average 24-hr ambulatory diastolic BP
Time Frame: From baseline to 2 months post-procedure
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From baseline to 2 months post-procedure
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Change in average office diastolic BP
Time Frame: From baseline to 2 months post-procedure
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From baseline to 2 months post-procedure
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Change in average home diastolic BP
Time Frame: From baseline to 2 months post-procedure
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From baseline to 2 months post-procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ajay Kirtane, MD, SM, Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation
- Principal Investigator: Prof. Michel Azizi, MD, PhD, Professor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 14, 2018
Primary Completion (Actual)
December 21, 2022
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
July 30, 2018
First Submitted That Met QC Criteria
July 30, 2018
First Posted (Actual)
August 3, 2018
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 20, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RADIANCE II Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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