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 :
Active, not recruiting
First Posted : August 3, 2018
Last Update Posted : June 22, 2023
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Condition or disease | Intervention/treatment | Phase |
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Hypertension Vascular Diseases Cardiovascular Diseases | Device: Paradise Renal Denervation System Procedure: Renal Angiogram | Not Applicable |
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 |
Actual Primary Completion Date : | December 21, 2022 |
Estimated Study Completion Date : | July 2027 |
Arm | Intervention/treatment |
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Experimental: Renal Denervation
Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)
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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:
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Sham Comparator: Sham Control
Renal Angiogram
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Procedure: Renal Angiogram
Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure. |
- 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 ]
- 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 ]
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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 |
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
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
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 |
Publications of Results:
Responsible Party: | ReCor Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT03614260 |
Other Study ID Numbers: |
RADIANCE II Study |
First Posted: | August 3, 2018 Key Record Dates |
Last Update Posted: | June 22, 2023 |
Last Verified: | June 2023 |
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 |
Denervation Resistant Hypertension Essential Hypertension Uncontrolled Hypertension |
Hypertension Cardiovascular Diseases Vascular Diseases |