Ireland
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Active, not recruiting Not applicable

RADIANCE Continued Access Protocol

NCT05017935 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2022-05-04
Last updated
2024-06-17

Condition(s) studied

HypertensionHypertension, Resistant to Conventional TherapyVascular DiseasesCardiovascular Diseases

Investigational drug(s) / intervention(s)

Renal Denervation

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of Adverse Events — From baseline to 60 months
  • Change in average daytime ambulatory systolic BP — From baseline to 2 months post procedure

Trial sites (40)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05017935 on ClinicalTrials.gov ↗ ← All trials in the USA