RADIANCE Continued Access Protocol (RADIANCE CAP)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Vascular Diseases; Hypertension; Hypertension, Resistant to Conventional Therapy
• Intervention / Treatment: Device: Renal Denervation

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helen Reeve-Stoffer, PhD; Phone Number: +44 7947 748006; Email: hreeve-stoffer@recormedical.com
• Study Contact Backup: Name: Elizabeth Sheehan, MLIS; Email: liz.sheehan@recormedical.com

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911
      • Cardiovascular Institute of San Diego
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Sacramento, California, United States, 95816
      • Sutter Health
    • Santa Monica, California, United States, 90404
      • Pacific Heart Institute
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
  • Florida
    • Gainesville, Florida, United States, 32604
      • The Cardiac and Vascular Institute
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
    • Orlando, Florida, United States, 32806
      • Orlando Health
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Springfield, Illinois, United States, 62701
      • Prairie Education And Research Cooperative
    • Springfield, Illinois, United States, 62794-9664
      • SIU Medicine
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Center
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • UnityPoint Health-Des Moines
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Lifebridge Health
    • Salisbury, Maryland, United States, 21804
      • Tidal Health
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 02120
      • The Brigham and Women's Hospital
    • Worcester, Massachusetts, United States, 01655
      • UMASS Memorial Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital
  • Nevada
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center
  • New Jersey
    • Haddon Heights, New Jersey, United States, 08035
      • Cardiovascular Associates of the Delaware Valley
    • Princeton, New Jersey, United States, 08540
      • NJ Heart & Vascular
  • New York
    • Mineola, New York, United States, 001501
      • NYU Langone Hospital - Long Island
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10032
      • Columbia University Medical Center/NYPH
    • Stony Brook, New York, United States, 11794-8167
      • Stony Brook University Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7075
      • University of North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Cone Health
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • St. Francis Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Medicine
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Heart and Vascular Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Sciences Center at Houston
    • Lubbock, Texas, United States, 79430
      • Texas Tech University Health Sciences Center
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Sciences Center, San Antonio
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Research Institute
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal Denervation	Device: Renal Denervation; Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: ReCor Medical, Inc.
• Investigators: Principal Investigator: Naomi Fisher, MD, Brigham and Women's Hospital/Harvard Medical School; Principal Investigator: Ajay Kirtane, MD, SM, Columbia University Medical Center/NYPH

Publications and helpful links

General Publications

• 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.

Helpful Links

• ReCor Medical company website
• Study eligibility questionnaire; study summary and information

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Blood Pressure; Uncontrolled Hypertension; Essential Hypertension; Resistant Hypertension; Denervation
• Additional Relevant MeSH Terms: Hypertension; Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: CLN-0932

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No