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

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: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Intervention / Treatment: Device: Paradise Renal Denervation System; Procedure: Renal Angiogram

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • Centre Hospitalier Universitaire Saint-Pierre
• France
  • Bordeaux, France, 33000
    • Hopital Saint André
  • Lille, France, 59000
    • CHRU de Lille
  • Paris, France, 75015
    • Hopital Europeen Georges-Pompidou (HEGP)
• Germany
  • Erlangen, Germany, D-91054
    • University Clinic Erlangen
  • Homburg, Germany, D-66421
    • University Clinic of Saarland - Homburg
  • Karlsruhe, Germany, 76133
    • Klinikum Karlsruhe GmbH
  • Konstanz, Germany, D-78464
    • Klinikum Konstanz
  • Leipzig, Germany, D-04289
    • Herzzentrum Leipzig GmbH
  • Lübeck, Germany, D-23560
    • Sana Kliniken Lübeck GmbH
• Ireland
  • Galway, Ireland, H91 YR71
    • University Hospital Galway
• Netherlands
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus Medical Center
• Switzerland
  • Geneva, Switzerland, 1211
    • Hôpitaux Universitaires Genève
• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • University Hospitals Dorset NHS Foundation Trust
  • Canterbury, United Kingdom, CT1 3NG
    • Kent & Canterbury Hospital
  • Cardiff, United Kingdom
    • University Hospital Wales
  • London, United Kingdom, EC1A 7BE
    • St Bartholomew's Hospital
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital
  • Essex
    • Basildon, Essex, United Kingdom, SS16 5NL
      • The Cardiothoracic Centre Basildon University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Cardiology PC
  • California
    • Los Angeles, California, United States, 940048
      • Cedars Sinai Medical Center
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
    • Stamford, Connecticut, United States, 06904
      • Stamford Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington
  • Florida
    • Gainesville, Florida, United States, 32605
      • The Cardiac and Vascular Institute
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Springfield, Illinois, United States, 62794
      • Southern Illinois University
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Heart and Vascular Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • The Brigham and Women's Hospital
  • Michigan
    • Traverse City, Michigan, United States, 49684
      • Munson Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Health System
  • Nevada
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart & Lung Center
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center/NYPH
    • New York, New York, United States, 10075
      • Northwell Health Inc.
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • The University of North Carolina at Chapel Hill
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • The University of Tennessee Health Science Center
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal Denervation; Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)	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.; Other Names: Renal Denervation; Renal Angiogram
Sham Comparator: Sham Control; Renal Angiogram	Procedure: Renal Angiogram; Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Major Adverse Events (MAE)	From baseline to 30 days post-procedure
Change in average daytime ambulatory systolic BP	From baseline to 2 months post-procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in average 24-hr ambulatory systolic BP	From baseline to 2 months post-procedure
Change in average office 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 daytime ambulatory diastolic BP	From baseline to 2 months post-procedure
Change in average 24-hr 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 home diastolic BP	From baseline to 2 months post-procedure

Collaborators and Investigators

• Sponsor: ReCor Medical, Inc.
• 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

General Publications

• 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. Erratum In: JAMA. 2023 Jun 13;329(22):1989. doi: 10.1001/jama.2023.8136.

Helpful Links

• Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial

Study record dates

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): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Uncontrolled Hypertension; Essential Hypertension; Resistant Hypertension; Denervation
• Additional Relevant MeSH Terms: Hypertension; Cardiovascular Diseases; Vascular Diseases
• 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