The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension (RADIANCE-II)

• ClinicalTrials.gov Identifier: NCT03614260
• Recruitment Status: Active, not recruiting
• First Posted: August 3, 2018
• Last Update Posted: October 6, 2022
• Sponsor: ReCor Medical, Inc.
• Information provided by (Responsible Party): ReCor Medical, Inc.

Tracking Information

• First Submitted Date: July 30, 2018
• First Posted Date: August 3, 2018
• Last Update Posted Date: October 6, 2022
• Actual Study Start Date: December 14, 2018
• Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 9, 2018)

• Incidence of Major Adverse Events (MAE) [ Time Frame: From baseline to 30 days post-procedure ]
• Change in average daytime ambulatory systolic BP [ Time Frame: From baseline to 2 months post-procedure ]

Original Primary Outcome Measures (submitted: July 30, 2018)

• Incidence of Major Adverse Events (MAE) [ Time Frame: From baseline to 30 days post-procedure ]
• Reduction in average daytime ambulatory systolic BP [ Time Frame: From baseline to 2 months post-procedure ]

Current Secondary Outcome Measures (submitted: August 9, 2018)

• Change in average 24-hr ambulatory systolic BP [ Time Frame: From baseline to 2 months post-procedure ]
• Change in average office systolic BP [ Time Frame: From baseline to 2 months post-procedure ]
• Change in average home systolic BP [ Time Frame: From baseline to 2 months post-procedure ]
• Change in average daytime ambulatory diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]
• Change in average 24-hr ambulatory diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]
• Change in average office diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]
• Change in average home diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]

Original Secondary Outcome Measures (submitted: July 30, 2018)

• Reduction in average 24-hr ambulatory systolic BP [ Time Frame: From baseline to 2 months post-procedure ]
• Reduction in average office systolic BP [ Time Frame: From baseline to 2 months post-procedure ]
• Reduction in average home systolic BP [ Time Frame: From baseline to 2 months post-procedure ]
• Reduction in average daytime ambulatory diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]
• Reduction in average 24-hr ambulatory diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]
• Reduction in average office diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]
• Reduction in average home diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
• Official Title: The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
• Brief Summary: The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Hypertension
• Vascular Diseases
• Cardiovascular Diseases

Intervention

• Device: Paradise Renal Denervation System
  Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
  Other Names:

  • Renal Angiogram
  • Renal Denervation
• Procedure: Renal Angiogram
  Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.

Study Arms

• Experimental: Renal Denervation
  Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)
  Intervention: Device: Paradise Renal Denervation System
• Sham Comparator: Sham Control
  Renal Angiogram
  Intervention: Procedure: Renal Angiogram

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 30, 2018): 225
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2027
• Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Previously or currently prescribed antihypertensive therapy
• Average office BP ≥ 140/90 mmHg <180/120 mmHg while stable for at least 4 weeks on 0-2 classes of antihypertensive medication
• Documented daytime ABP ≥ 135/85 mmHg and < 170/105 mmHg after 4-week washout/run-in period

Exclusion Criteria:

• Lacks appropriate renal artery anatomy for treatment
• Known, uncorrected causes of secondary hypertension other than sleep apnea
• Type I diabetes mellitus or uncontrolled Type II diabetes
• eGFR of <40
• Brachial circumference ≥ 42 cm
• Any history of cerebrovascular event or severe cardiovascular event, or history of stable or unstable angina within 12 months prior to consent
• Repeat (>1) hospitalization for hypertensive crisis within 12 months prior to screening period, or any hospitalization for hypertensive crisis within 3 months prior to screening period
• 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: Belgium, France, Germany, Ireland, Netherlands, Switzerland, United Kingdom, United States

Administrative Information

• NCT Number: NCT03614260
• Other Study ID Numbers: RADIANCE II Study
• Has Data Monitoring Committee: Not Provided

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: Ajay Kirtane, MD, SM; Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation
• Principal Investigator: Prof. Michel Azizi, MD, PhD; Professor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou

• PRS Account: ReCor Medical, Inc.
• Verification Date: October 2022