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

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ClinicalTrials.gov Identifier: NCT03614260
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
ReCor Medical, Inc.

Tracking Information
First Submitted Date  ICMJE July 30, 2018
First Posted Date  ICMJE August 3, 2018
Last Update Posted Date December 4, 2020
Actual Study Start Date  ICMJE December 14, 2018
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Vascular Diseases
  • Cardiovascular Diseases
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 30, 2018)
225
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2026
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Helen Reeve-Stoffer, PhD +44 7947 748006 hreeve-stoffer@recormedical.com
Contact: Tracy Rodriguez +1 650 542 7721 trodriguez@recormedical.com
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Ireland,   Netherlands,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03614260
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party ReCor Medical, Inc.
Study Sponsor  ICMJE ReCor Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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 December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP