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NCT05017935 Clinical Trial

RADIANCE Continued Access Protocol

Hypertension Clinical Trial

— RADIANCE CAP  

Official title:
RADIANCE Continued Access Protocol (RADIANCE CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05017935
Other study ID # CLN-0932
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 4, 2022
Est. completion date December 31, 2028

Study information
Verified date June 2024
Source ReCor Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date December 31, 2028
Est. primary completion date December 31, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Related Conditions & MeSH terms

Intervention

Device:
• Renal Denervation
Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System)

Locations
Country Name City State
United States Emory Atlanta Georgia
United States Lifebridge Health Baltimore Maryland
United States Boston Medical Center Boston Massachusetts
United States The Brigham and Women's Hospital Boston Massachusetts
United States Bridgeport Hospital Bridgeport Connecticut
United States University of North Carolina Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Northwestern University Chicago Illinois
United States Cardiovascular Institute of San Diego Chula Vista California
United States UnityPoint Health-Des Moines Des Moines Iowa
United States Henry Ford Hospital Detroit Michigan
United States Parkview Research Center Fort Wayne Indiana
United States The Cardiac and Vascular Institute Gainesville Florida
United States Cone Health Greensboro North Carolina
United States Cardiovascular Associates of the Delaware Valley Haddon Heights New Jersey
United States The University of Texas Health Sciences Center at Houston Houston Texas
United States Saint Luke's Hospital Kansas City Missouri
United States Cedars-Sinai Medical Center Los Angeles California
United States Texas Tech University Health Sciences Center Lubbock Texas
United States Baptist Hospital of Miami Miami Florida
United States NYU Langone Hospital - Long Island Mineola New York
United States Ochsner Medical Center New Orleans Louisiana
United States Columbia University Medical Center/NYPH New York New York
United States NYU Langone Health New York New York
United States Orlando Health Orlando Florida
United States Penn Medicine Philadelphia Pennsylvania
United States UPMC Heart and Vascular Center Pittsburgh Pennsylvania
United States NJ Heart & Vascular Princeton New Jersey
United States Renown Regional Medical Center Reno Nevada
United States Sutter Health Sacramento California
United States Tidal Health Salisbury Maryland
United States University of Texas Health Sciences Center, San Antonio San Antonio Texas
United States Pacific Heart Institute Santa Monica California
United States Swedish Health Services Seattle Washington
United States Prairie Education and Research Cooperative Springfield Illinois
United States SIU Medicine Springfield Illinois
United States Stony Brook University Hospital Stony Brook New York
United States Baylor Scott & White Research Institute Temple Texas
United States St. Francis Hospital Tulsa Oklahoma
United States UMASS Memorial Medical Center Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
ReCor Medical, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events From baseline to 60 months
Primary Change in average daytime ambulatory systolic BP From baseline to 2 months post procedure
Secondary Change in average 24-hr/night-time ambulatory systolic BP From baseline to 2 months post procedure
Secondary Change in average daytime/24-hr/night-time ambulatory systolic BP From Baseline to Months 6 and 12 post procedure
Secondary Change in average office systolic/diastolic BP From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure
Secondary Change in average home systolic/diastolic BP From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure
Secondary Change in average 24-hr/night-time ambulatory diastolic BP From baseline to Months 2, 6, and 12 post procedure
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