The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
- Conditions
- Cardiovascular DiseasesVascular DiseasesHypertension
- Interventions
- Device: Paradise Renal Denervation SystemProcedure: Renal Angiogram
- Registration Number
- NCT03614260
- Lead Sponsor
- ReCor Medical, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 225
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Renal Denervation Paradise Renal Denervation System Renal Angiogram and Renal Denervation (Paradise Renal Denervation System) Sham Control Renal Angiogram Renal Angiogram
- Primary Outcome Measures
Name Time Method Change in average daytime ambulatory systolic BP From baseline to 2 months post-procedure Incidence of Major Adverse Events (MAE) From baseline to 30 days post-procedure
- Secondary Outcome Measures
Name Time Method Change in average 24-hr ambulatory diastolic BP From baseline to 2 months post-procedure Change in average office systolic BP From baseline to 2 months post-procedure Change in average daytime ambulatory diastolic BP From baseline to 2 months post-procedure Change in average office diastolic BP From baseline to 2 months post-procedure Change in average 24-hr ambulatory systolic BP From baseline to 2 months post-procedure Change in average home systolic BP From baseline to 2 months post-procedure Change in average home diastolic BP From baseline to 2 months post-procedure
Trial Locations
- Locations (47)
Deborah Heart & Lung Center
🇺🇸Browns Mills, New Jersey, United States
Hackensack University
🇺🇸Hackensack, New Jersey, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
The Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Ochsner Heart and Vascular Institute
🇺🇸New Orleans, Louisiana, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
The Cardiac and Vascular Institute
🇺🇸Gainesville, Florida, United States
MedStar Washington
🇺🇸Washington, District of Columbia, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Southern Illinois University
🇺🇸Springfield, Illinois, United States
Saint Luke's Health System
🇺🇸Kansas City, Missouri, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, 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
The University of Tennessee Health Science Center
🇺🇸Memphis, Tennessee, United States
CHRU de Lille
🇫🇷Lille, France
University Clinic Erlangen
🇩🇪Erlangen, Germany
Hôpital Européen Georges-Pompidou (HEGP)
🇫🇷Paris, France
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
The Cardiothoracic Centre Basildon University Hospital
🇬🇧Basildon, Essex, United Kingdom
University Hospitals Dorset NHS Foundation Trust
🇬🇧Bournemouth, United Kingdom
University Hospital Wales
🇬🇧Cardiff, United Kingdom
Kent & Canterbury Hospital
🇬🇧Canterbury, United Kingdom
Cardiology PC
🇺🇸Birmingham, Alabama, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Hôpital Saint André
🇫🇷Bordeaux, France
St Bartholomew's Hospital
🇬🇧London, United Kingdom
Freeman Hospital
🇬🇧Newcastle Upon Tyne, United Kingdom
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Centre Hospitalier Universitaire Saint-Pierre
🇧🇪Brussels, Belgium
Hôpitaux Universitaires Genève
🇨🇭Geneva, Switzerland
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States