RADIANCE Continued Access Protocol

Running, not enrolling · Not applicable

Conditions studied: Hypertension, Hypertension, Resistant to Conventional Therapy, Vascular Diseases, Cardiovascular Diseases

In brief

RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.

Key facts

Study ID

NCT05017935

Run by

ReCor Medical, Inc.

People needed

300

Starts

2022-05-04

Expected to finish

2028-12-31

Last updated by the study team

2024-06-17

Who can join

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

You may qualify if…

• Average office BP ≥140/90 mmHg at screening visit despite taking stables doses of antihypertensive medications for at least 4 weeks prior to consent
• Documented daytime ABP ≥135/85 mmHg following 4 week run-in/standardization period on antihypertensive medication regimen

You may not qualify if…

• Renal artery anatomy ineligible for treatment
• Secondary hypertension not including sleep apnea
• Type I diabetes mellitus or uncontrolled Type II diabetes (defined as plasma HbA1c ≥9.0%)
• eGFR <40
• Brachial circumference ≥42 cm
• Any history of cerebrovascular event or severe cardiovascular event within 3 months prior to consent
• Documented repeat (>1) hospitalization for hypertensive crisis within 3 months prior to consent
• Documented confirmed episode(s) of unstable angina within 3 months prior to consent
• 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

• Cardiovascular Institute of San Diego — Chula Vista, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Sutter Health — Sacramento, California, United States
• Pacific Heart Institute — Santa Monica, California, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• The Cardiac and Vascular Institute — Gainesville, Florida, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• Orlando Health — Orlando, Florida, United States
• Emory — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• SIU Medicine — Springfield, Illinois, United States
• Parkview Research Center — Fort Wayne, Indiana, United States
• UnityPoint Health-Des Moines — Des Moines, Iowa, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Lifebridge Health — Baltimore, Maryland, United States
• Tidal Health — Salisbury, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• The Brigham and Women's Hospital — Boston, Massachusetts, United States
• UMASS Memorial Medical Center — Worcester, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Saint Luke's Hospital — Kansas City, Missouri, United States
• Renown Regional Medical Center — Reno, Nevada, United States
• Cardiovascular Associates of the Delaware Valley — Haddon Heights, New Jersey, United States
• NJ Heart & Vascular — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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