RADIANCE Continued Access Protocol (RADIANCE CAP)

• ClinicalTrials.gov Identifier: NCT05017935
• Recruitment Status: Active, not recruiting
• First Posted: August 24, 2021
• Last Update Posted: March 4, 2024
• Sponsor: ReCor Medical, Inc.
• Information provided by (Responsible Party): ReCor Medical, Inc.

Tracking Information

• First Submitted Date: August 17, 2021
• First Posted Date: August 24, 2021
• Last Update Posted Date: March 4, 2024
• Actual Study Start Date: May 4, 2022
• Estimated Primary Completion Date: December 31, 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 17, 2021)

• Incidence of Adverse Events [ Time Frame: From baseline to 60 months ]
• Change in average daytime ambulatory systolic BP [ Time Frame: From baseline to 2 months post procedure ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 17, 2021)

• Change in average 24-hr/night-time ambulatory systolic BP [ Time Frame: From baseline to 2 months post procedure ]
• Change in average daytime/24-hr/night-time ambulatory systolic BP [ Time Frame: From Baseline to Months 6 and 12 post procedure ]
• Change in average office systolic/diastolic BP [ Time Frame: From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure ]
• Change in average home systolic/diastolic BP [ Time Frame: From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure ]
• Change in average 24-hr/night-time ambulatory diastolic BP [ Time Frame: From baseline to Months 2, 6, and 12 post procedure ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: RADIANCE Continued Access Protocol
• Official Title: RADIANCE Continued Access Protocol (RADIANCE CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Hypertension
• Hypertension, Resistant to Conventional Therapy
• Vascular Diseases
• Cardiovascular Diseases

Intervention

Device: Renal Denervation

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

Study Arms

Experimental: Renal Denervation

Intervention: Device: Renal Denervation

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 29, 2022): 300
• Original Estimated Enrollment (submitted: August 17, 2021): 150
• Estimated Study Completion Date: December 31, 2028
• Estimated Primary Completion Date: December 31, 2028 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05017935
• Other Study ID Numbers: CLN-0932
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

• IPD Sharing Statement: Not Provided
• Current Responsible Party: ReCor Medical, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: ReCor Medical, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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

• PRS Account: ReCor Medical, Inc.
• Verification Date: February 2024