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RADIANCE Continued Access Protocol (RADIANCE CAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05017935
Recruitment Status : Active, not recruiting
First Posted : August 24, 2021
Last Update Posted : March 4, 2024
Sponsor:
Information provided by (Responsible Party):
ReCor Medical, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Hypertension, Resistant to Conventional Therapy Vascular Diseases Cardiovascular Diseases Device: Renal Denervation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RADIANCE Continued Access Protocol (RADIANCE CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension
Actual Study Start Date : May 4, 2022
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Renal Denervation Device: Renal Denervation
Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System)


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: From baseline to 60 months ]
  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/night-time ambulatory systolic BP [ Time Frame: From baseline to 2 months post procedure ]
  2. Change in average daytime/24-hr/night-time ambulatory systolic BP [ Time Frame: From Baseline to Months 6 and 12 post procedure ]
  3. Change in average office systolic/diastolic BP [ Time Frame: From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure ]
  4. Change in average home systolic/diastolic BP [ Time Frame: From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure ]
  5. Change in average 24-hr/night-time ambulatory diastolic BP [ Time Frame: From baseline to Months 2, 6, and 12 post procedure ]

Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT05017935


Locations
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Sponsors and Collaborators
ReCor Medical, Inc.
Investigators
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Principal Investigator: Naomi Fisher, MD Brigham and Women's Hospital/Harvard Medical School
Principal Investigator: Ajay Kirtane, MD, SM Columbia University Medical Center/NYPH
More Information
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Additional Information:

Publications:

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Responsible Party: ReCor Medical, Inc.
ClinicalTrials.gov Identifier: NCT05017935    
Other Study ID Numbers: CLN-0932
First Posted: August 24, 2021    Key Record Dates
Last Update Posted: March 4, 2024
Last Verified: February 2024

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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
Keywords provided by ReCor Medical, Inc.:
Blood Pressure
Uncontrolled Hypertension
Essential Hypertension
Resistant Hypertension
Denervation
Additional relevant MeSH terms:
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Hypertension
Cardiovascular Diseases
Vascular Diseases