RADIANCE Continued Access Protocol
- Conditions
- HypertensionVascular DiseasesHypertension, Resistant to Conventional TherapyCardiovascular Diseases
- Interventions
- Device: Renal Denervation
- Registration Number
- NCT05017935
- Lead Sponsor
- ReCor Medical, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Renal Denervation Renal Denervation -
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events From baseline to 60 months Change in average daytime ambulatory systolic BP From baseline to 2 months post procedure
- Secondary Outcome Measures
Name Time Method Change in average 24-hr/night-time ambulatory systolic BP From baseline to 2 months post procedure Change in average daytime/24-hr/night-time ambulatory systolic BP From Baseline to Months 6 and 12 post procedure Change in average home systolic/diastolic BP From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure Change in average 24-hr/night-time ambulatory diastolic BP From baseline to Months 2, 6, and 12 post procedure Change in average office systolic/diastolic BP From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure
Trial Locations
- Locations (40)
Cardiovascular Associates of the Delaware Valley
🇺🇸Haddon Heights, New Jersey, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
NJ Heart & Vascular
🇺🇸Princeton, New Jersey, United States
UMASS Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Cardiovascular Institute of San Diego
🇺🇸Chula Vista, California, United States
Baylor Scott & White Research Institute
🇺🇸Temple, Texas, United States
NYU Langone Hospital - Long Island
🇺🇸Mineola, New York, United States
SIU Medicine
🇺🇸Springfield, Illinois, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Pacific Heart Institute
🇺🇸Santa Monica, California, United States
St. Francis Hospital
🇺🇸Tulsa, Oklahoma, United States
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Penn Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Texas Tech University Health Sciences Center
🇺🇸Lubbock, Texas, United States
Parkview Research Center
🇺🇸Fort Wayne, Indiana, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Emory
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
The Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
The University of Texas Health Sciences Center at Houston
🇺🇸Houston, Texas, United States
Swedish Health Services
🇺🇸Seattle, Washington, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
University of Texas Health Sciences Center, San Antonio
🇺🇸San Antonio, Texas, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Columbia University Medical Center/NYPH
🇺🇸New York, New York, United States
Tidal Health
🇺🇸Salisbury, Maryland, United States
Lifebridge Health
🇺🇸Baltimore, Maryland, United States
UPMC Heart and Vascular Center
🇺🇸Pittsburgh, Pennsylvania, United States
Cone Health
🇺🇸Greensboro, North Carolina, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
NYU Langone Health
🇺🇸New York, New York, United States
Sutter Health
🇺🇸Sacramento, California, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
The Cardiac and Vascular Institute
🇺🇸Gainesville, Florida, United States
Saint Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Orlando Health
🇺🇸Orlando, Florida, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
UnityPoint Health-Des Moines
🇺🇸Des Moines, Iowa, United States