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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 : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
ReCor Medical, Inc.

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.

Condition or disease Intervention/treatment Phase
Hypertension Vascular Diseases Cardiovascular Diseases Device: Paradise Renal Denervation System Procedure: Renal Angiogram Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
Actual Study Start Date : December 14, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Renal Denervation
Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)
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

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




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

Secondary Outcome Measures :
  1. Change in average 24-hr ambulatory systolic BP [ Time Frame: From baseline to 2 months post-procedure ]
  2. Change in average office systolic BP [ Time Frame: From baseline to 2 months post-procedure ]
  3. Change in average home systolic BP [ Time Frame: From baseline to 2 months post-procedure ]
  4. Change in average daytime ambulatory diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]
  5. Change in average 24-hr ambulatory diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]
  6. Change in average office diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]
  7. Change in average home diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614260


Contacts
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Contact: Helen Reeve-Stoffer, PhD +44 7947 748006 hreeve-stoffer@recormedical.com
Contact: Meital Horesh-Bar, BA +1 650 542-9785 mhoresh-bar@recormedical.com

  Show 39 Study Locations
Sponsors and Collaborators
ReCor Medical, Inc.
Investigators
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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

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Responsible Party: ReCor Medical, Inc.
ClinicalTrials.gov Identifier: NCT03614260     History of Changes
Other Study ID Numbers: RADIANCE II Study
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by ReCor Medical, Inc.:
Denervation
Resistant Hypertension
Essential Hypertension
Uncontrolled Hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases