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Clinical Trials in France / NCT03614260
Active, not recruiting Not applicable

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

NCT03614260 · tracked via the Priya Life Science France tracker
Sponsor
ReCor Medical, Inc
Phase
Not applicable
Started
2018-12-14
Last updated
2026-09-24

Condition(s) studied

HypertensionVascular DiseasesCardiovascular Diseases

Investigational drug(s) / intervention(s)

Paradise Renal Denervation SystemRenal Angiogram

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.

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

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)

  • Change in Average Daytime Ambulatory Systolic BP — From baseline to 2 months post-procedure
    The primary efficacy outcome is the mean change in daytime ambulatory systolic blood pressure at 2 months
  • Percentage of Participants With Major Adverse Events (MAE) — From baseline to 30 days post-procedure
    The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular, and hypertensive events at 30 days.

Trial sites (47)

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

+ 7 more sites — see the full list on the official registry below.

More ReCor Medical, Inc. trials in France

The "Global Paradise System" Registry Recruiting
A Study of the ReCor Medical Paradise System in Clinical Hypertension Active, not recruiting

Other trials for the same condition

The "Global Paradise System" Registry Recruiting
Identification of New Biomarkers for the Prediction of Cardiovascular Events Recruiting
Validation Study of WITHINGS BPM Core for the Detection of Atrial Fibrillation Active, not recruiting
Hyperlipoproteinemia A as a Marker of Cardiovascular Risk in Patients With Stage 4 Chronic Kidney Disease Starting soon
The Effect of Oral SPM Supplementation on INflammation-induced Vascular Ageing in Obese Hypertensive Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03614260 on ClinicalTrials.gov ↗ ← All trials in France