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

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Hypertension, Vascular Diseases, Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT03614260

Run by

ReCor Medical, Inc.

People needed

225

Starts

2018-12-14

Expected to finish

2027-07-01

Last updated by the study team

2025-04-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cardiology PC — Birmingham, Alabama, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Stamford Hospital — Stamford, Connecticut, United States
• MedStar Washington — Washington D.C., District of Columbia, United States
• The Cardiac and Vascular Institute — Gainesville, Florida, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Southern Illinois University — Springfield, Illinois, United States
• Ochsner Heart and Vascular Institute — New Orleans, Louisiana, United States
• The Brigham and Women's Hospital — Boston, Massachusetts, United States
• Munson Medical Center — Traverse City, Michigan, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Saint Luke's Health System — Kansas City, Missouri, United States
• Renown Regional Medical Center — Reno, Nevada, United States
• Deborah Heart & Lung Center — Browns Mills, New Jersey, United States
• Hackensack University — Hackensack, New Jersey, United States
• Columbia University Medical Center/NYPH — New York, New York, United States
• Northwell Health Inc. — New York, New York, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• The University of Tennessee Health Science Center — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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