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

Primary Purpose

Hypertension, Vascular Diseases, Cardiovascular Diseases

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Paradise Renal Denervation System
Renal Angiogram
Sponsored by
ReCor Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Denervation, Resistant Hypertension, Essential Hypertension, Uncontrolled Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiology PC
  • Cedars Sinai Medical Center
  • Bridgeport Hospital
  • Stamford Hospital
  • MedStar Washington
  • The Cardiac and Vascular Institute
  • Emory University Hospital Midtown
  • Northwestern University
  • Southern Illinois University
  • Ochsner Heart and Vascular Institute
  • The Brigham and Women's Hospital
  • Munson Medical Center
  • Minneapolis Heart Institute Foundation
  • Saint Luke's Health System
  • Renown Regional Medical Center
  • Deborah Heart & Lung Center
  • Hackensack University
  • Columbia University Medical Center/NYPH
  • Northwell Health Inc.
  • The University of North Carolina at Chapel Hill
  • Cleveland Clinic
  • University of Pennsylvania Health System
  • University of Pittsburgh Medical Center
  • Medical University of South Carolina
  • The University of Tennessee Health Science Center
  • Vanderbilt University
  • University of Utah
  • Swedish Medical Center
  • Centre Hospitalier Universitaire Saint-Pierre
  • Hôpital Saint André
  • CHRU de Lille
  • Hôpital Européen Georges-Pompidou (HEGP)
  • University Clinic Erlangen
  • University Clinic of Saarland - Homburg
  • Klinikum Karlsruhe GmbH
  • Klinikum Konstanz
  • Herzzentrum Leipzig GmbH
  • Sana Kliniken Lübeck GmbH
  • University Hospital Galway
  • Erasmus Medical Center
  • Hôpitaux Universitaires Genève
  • The Cardiothoracic Centre Basildon University Hospital
  • University Hospitals Dorset NHS Foundation Trust
  • Kent & Canterbury Hospital
  • University Hospital Wales
  • St Bartholomew's Hospital
  • Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Renal Denervation

Sham Control

Arm Description

Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)

Renal Angiogram

Outcomes

Primary Outcome Measures

Incidence of Major Adverse Events (MAE)
Change in average daytime ambulatory systolic BP

Secondary Outcome Measures

Change in average 24-hr ambulatory systolic BP
Change in average office systolic BP
Change in average home systolic BP
Change in average daytime ambulatory diastolic BP
Change in average 24-hr ambulatory diastolic BP
Change in average office diastolic BP
Change in average home diastolic BP

Full Information

First Posted
July 30, 2018
Last Updated
June 20, 2023
Sponsor
ReCor Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03614260
Brief Title
The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
Acronym
RADIANCE-II
Official Title
The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 14, 2018 (Actual)
Primary Completion Date
December 21, 2022 (Actual)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ReCor Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Vascular Diseases, Cardiovascular Diseases
Keywords
Denervation, Resistant Hypertension, Essential Hypertension, Uncontrolled Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Renal Denervation
Arm Type
Experimental
Arm Description
Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)
Arm Title
Sham Control
Arm Type
Sham Comparator
Arm Description
Renal Angiogram
Intervention Type
Device
Intervention Name(s)
Paradise Renal Denervation System
Other Intervention Name(s)
Renal Angiogram, Renal Denervation
Intervention Description
Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
Intervention Type
Procedure
Intervention Name(s)
Renal Angiogram
Intervention Description
Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.
Primary Outcome Measure Information:
Title
Incidence of Major Adverse Events (MAE)
Time Frame
From baseline to 30 days post-procedure
Title
Change in average daytime ambulatory systolic BP
Time Frame
From baseline to 2 months post-procedure
Secondary Outcome Measure Information:
Title
Change in average 24-hr ambulatory systolic BP
Time Frame
From baseline to 2 months post-procedure
Title
Change in average office systolic BP
Time Frame
From baseline to 2 months post-procedure
Title
Change in average home systolic BP
Time Frame
From baseline to 2 months post-procedure
Title
Change in average daytime ambulatory diastolic BP
Time Frame
From baseline to 2 months post-procedure
Title
Change in average 24-hr ambulatory diastolic BP
Time Frame
From baseline to 2 months post-procedure
Title
Change in average office diastolic BP
Time Frame
From baseline to 2 months post-procedure
Title
Change in average home diastolic BP
Time Frame
From baseline to 2 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajay Kirtane, MD, SM
Organizational Affiliation
Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof. Michel Azizi, MD, PhD
Organizational Affiliation
Professor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
940048
Country
United States
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Stamford Hospital
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Facility Name
MedStar Washington
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
The Cardiac and Vascular Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Southern Illinois University
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Facility Name
Ochsner Heart and Vascular Institute
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
The Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Saint Luke's Health System
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Deborah Heart & Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Hackensack University
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Columbia University Medical Center/NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Northwell Health Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
The University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Centre Hospitalier Universitaire Saint-Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hôpital Saint André
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hôpital Européen Georges-Pompidou (HEGP)
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
University Clinic Erlangen
City
Erlangen
ZIP/Postal Code
D-91054
Country
Germany
Facility Name
University Clinic of Saarland - Homburg
City
Homburg
ZIP/Postal Code
D-66421
Country
Germany
Facility Name
Klinikum Karlsruhe GmbH
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Klinikum Konstanz
City
Konstanz
ZIP/Postal Code
D-78464
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
ZIP/Postal Code
D-04289
Country
Germany
Facility Name
Sana Kliniken Lübeck GmbH
City
Lübeck
ZIP/Postal Code
D-23560
Country
Germany
Facility Name
University Hospital Galway
City
Galway
ZIP/Postal Code
H91 YR71
Country
Ireland
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Hôpitaux Universitaires Genève
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
The Cardiothoracic Centre Basildon University Hospital
City
Basildon
State/Province
Essex
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Facility Name
University Hospitals Dorset NHS Foundation Trust
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Kent & Canterbury Hospital
City
Canterbury
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
University Hospital Wales
City
Cardiff
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36853250
Citation
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.
Results Reference
result
Links:
URL
https://jamanetwork.com/journals/jama/article-abstract/2801849
Description
Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial

Learn more about this trial

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

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