RADIANCE Continued Access Protocol
RADIANCE CAP
1 other identifier
interventional
300
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started May 2022
Longer than P75 for not_applicable hypertension
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2021
CompletedFirst Posted
Study publicly available on registry
August 24, 2021
CompletedStudy Start
First participant enrolled
May 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
June 17, 2024
June 1, 2024
6.7 years
August 17, 2021
June 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Adverse Events
From baseline to 60 months
Change in average daytime ambulatory systolic BP
From baseline to 2 months post procedure
Secondary Outcomes (5)
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 office systolic/diastolic BP
From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 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
Study Arms (1)
Renal Denervation
EXPERIMENTALInterventions
Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System)
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Cardiovascular Institute of San Diego
Chula Vista, California, 91911, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Sutter Health
Sacramento, California, 95816, United States
Pacific Heart Institute
Santa Monica, California, 90404, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
The Cardiac and Vascular Institute
Gainesville, Florida, 32604, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Orlando Health
Orlando, Florida, 32806, United States
Emory
Atlanta, Georgia, 30308, United States
Northwestern University
Chicago, Illinois, 60611, United States
Prairie Education and Research Cooperative
Springfield, Illinois, 62701, United States
SIU Medicine
Springfield, Illinois, 62794-9664, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
UnityPoint Health-Des Moines
Des Moines, Iowa, 50309, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Lifebridge Health
Baltimore, Maryland, 21215, United States
Tidal Health
Salisbury, Maryland, 21804, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
The Brigham and Women's Hospital
Boston, Massachusetts, 02120, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08035, United States
NJ Heart & Vascular
Princeton, New Jersey, 08540, United States
NYU Langone Hospital - Long Island
Mineola, New York, 001501, United States
NYU Langone Health
New York, New York, 10016, United States
Columbia University Medical Center/NYPH
New York, New York, 10032, United States
Stony Brook University Hospital
Stony Brook, New York, 11794-8167, United States
University of North Carolina
Chapel Hill, North Carolina, 27599-7075, United States
Cone Health
Greensboro, North Carolina, 27401, United States
St. Francis Hospital
Tulsa, Oklahoma, 74136, United States
Penn Medicine
Philadelphia, Pennsylvania, 19104, United States
UPMC Heart and Vascular Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
The University of Texas Health Sciences Center at Houston
Houston, Texas, 77030, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
University of Texas Health Sciences Center, San Antonio
San Antonio, Texas, 78229, United States
Baylor Scott & White Research Institute
Temple, Texas, 76508, United States
Swedish Health Services
Seattle, Washington, 98122, United States
Related Publications (1)
Azizi M, Sanghvi K, Saxena M, Gosse P, Reilly JP, Levy T, Rump LC, Persu A, Basile J, Bloch MJ, Daemen J, Lobo MD, Mahfoud F, Schmieder RE, Sharp ASP, Weber MA, Sapoval M, Fong P, Pathak A, Lantelme P, Hsi D, Bangalore S, Witkowski A, Weil J, Kably B, Barman NC, Reeve-Stoffer H, Coleman L, McClure CK, Kirtane AJ; RADIANCE-HTN investigators. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet. 2021 Jun 26;397(10293):2476-2486. doi: 10.1016/S0140-6736(21)00788-1. Epub 2021 May 16.
PMID: 34010611BACKGROUND
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Naomi Fisher, MD
Brigham and Women's Hospital/Harvard Medical School
- PRINCIPAL INVESTIGATOR
Ajay Kirtane, MD, SM
Columbia University Medical Center/NYPH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2021
First Posted
August 24, 2021
Study Start
May 4, 2022
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
June 17, 2024
Record last verified: 2024-06