Clinical trial NCT03614260: The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
Official title: The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Vascular Diseases
Cardiovascular Diseases
Keywords: Denervation
Resistant Hypertension
Essential Hypertension
Uncontrolled Hypertension
Lead sponsor: ReCor Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-03
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of Major Adverse Events (MAE)
timeFrame: From baseline to 30 days post-procedure
measure: Change in average daytime ambulatory systolic BP
timeFrame: From baseline to 2 months post-procedure
Secondary outcomes:
measure: Change in average 24-hr ambulatory systolic BP
timeFrame: From baseline to 2 months post-procedure
measure: Change in average office systolic BP
timeFrame: From baseline to 2 months post-procedure
measure: Change in average home systolic BP
timeFrame: From baseline to 2 months post-procedure
measure: Change in average daytime ambulatory diastolic BP
timeFrame: From baseline to 2 months post-procedure
measure: Change in average 24-hr ambulatory diastolic BP
timeFrame: From baseline to 2 months post-procedure
measure: Change in average office diastolic BP
timeFrame: From baseline to 2 months post-procedure
measure: Change in average home diastolic BP
timeFrame: From baseline to 2 months post-procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology PC
state: Alabama
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington
state: District of Columbia
city: Gainesville
country: United States
facility: The Cardiac and Vascular Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Heart and Vascular Institute
state: Louisiana
city: Boston
country: United States
facility: The Brigham and Women's Hospital
state: Massachusetts
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Health System
state: Missouri
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Browns Mills
country: United States
facility: Deborah Heart & Lung Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: New York
country: United States
facility: Northwell Health Inc.
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: The University of Tennessee Health Science Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Brussels
country: Belgium
facility: Centre Hospitalier Universitaire Saint-Pierre
city: Bordeaux
country: France
facility: Hôpital Saint André
city: Lille
country: France
facility: CHRU de Lille
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou (HEGP)
city: Erlangen
country: Germany
facility: University Clinic Erlangen
city: Homburg
country: Germany
facility: University Clinic of Saarland - Homburg
city: Karlsruhe
country: Germany
facility: Klinikum Karlsruhe GmbH
city: Konstanz
country: Germany
facility: Klinikum Konstanz
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Lübeck
country: Germany
facility: Sana Kliniken Lübeck GmbH
city: Galway
country: Ireland
facility: University Hospital Galway
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires Genève
city: Basildon
country: United Kingdom
facility: The Cardiothoracic Centre Basildon University Hospital
state: Essex
city: Bournemouth
country: United Kingdom
facility: University Hospitals Dorset NHS Foundation Trust
city: Canterbury
country: United Kingdom
facility: Kent & Canterbury Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital Wales
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation
name: Ajay Kirtane, MD, SM
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou
name: Prof. Michel Azizi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.