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NCT03614260 Clinical Trial

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

Hypertension Clinical Trial

— RADIANCE-II  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03614260
Other study ID # RADIANCE II Study
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 14, 2018
Est. completion date July 2027

Study information
Verified date June 2023
Source ReCor Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 225
Est. completion date July 2027
Est. primary completion date December 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• 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.
Procedure:
• Renal Angiogram
Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.

Locations
Country Name City State
Belgium Centre Hospitalier Universitaire Saint-Pierre Brussels
France Hôpital Saint André Bordeaux
France CHRU de Lille Lille
France Hôpital Européen Georges-Pompidou (HEGP) Paris
Germany 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
Ireland University Hospital Galway Galway
Netherlands Erasmus Medical Center Rotterdam
Switzerland Hôpitaux Universitaires Genève Geneva
United Kingdom 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 States Emory University Hospital Midtown Atlanta Georgia
United States Cardiology PC Birmingham Alabama
United States The Brigham and Women's Hospital Boston Massachusetts
United States Bridgeport Hospital Bridgeport Connecticut
United States Deborah Heart & Lung Center Browns Mills New Jersey
United States The University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Northwestern University Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States The Cardiac and Vascular Institute Gainesville Florida
United States Hackensack University Hackensack New Jersey
United States Saint Luke's Health System Kansas City Missouri
United States Cedars Sinai Medical Center Los Angeles California
United States The University of Tennessee Health Science Center Memphis Tennessee
United States Minneapolis Heart Institute Foundation Minneapolis Minnesota
United States Vanderbilt University Nashville Tennessee
United States Ochsner Heart and Vascular Institute New Orleans Louisiana
United States Columbia University Medical Center/NYPH New York New York
United States Northwell Health Inc. New York New York
United States University of Pennsylvania Health System Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Renown Regional Medical Center Reno Nevada
United States University of Utah Salt Lake City Utah
United States Swedish Medical Center Seattle Washington
United States Southern Illinois University Springfield Illinois
United States Stamford Hospital Stamford Connecticut
United States Munson Medical Center Traverse City Michigan
United States MedStar Washington Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
ReCor Medical, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Ireland,  Netherlands,  Switzerland,  United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Major Adverse Events (MAE) From baseline to 30 days post-procedure
Primary Change in average daytime ambulatory systolic BP From baseline to 2 months post-procedure
Secondary Change in average 24-hr ambulatory systolic BP From baseline to 2 months post-procedure
Secondary Change in average office systolic BP From baseline to 2 months post-procedure
Secondary Change in average home systolic BP From baseline to 2 months post-procedure
Secondary Change in average daytime ambulatory diastolic BP From baseline to 2 months post-procedure
Secondary Change in average 24-hr ambulatory diastolic BP From baseline to 2 months post-procedure
Secondary Change in average office diastolic BP From baseline to 2 months post-procedure
Secondary Change in average home diastolic BP From baseline to 2 months post-procedure
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