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

  • STATUS
    Recruiting
  • End date
    Dec 10, 2026
  • participants needed
    225
  • sponsor
    ReCor Medical, Inc.
Updated on 10 July 2021
Investigator
Ian Halliday
Primary Contact
The Brigham and Women's Hospital (1.8 mi away) Contact
+82 other location
angiography
hypertension
antihypertensive drugs
hypertensive medication
antihypertensive therapy
renal angiogram

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.

Details
Condition Vascular Diseases, Hypertension, Cardiovascular Disease, Diabetes and Hypertension, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric), Elevated Blood Pressure, vascular disorder, high blood pressure, arterial hypertension, cardiovascular diseases, cardiovascular disease (cvd), cardiovascular system diseases, cardiovascular disorders, vascular disease, vasculopathy, vasc
Treatment Paradise Renal Denervation System, Renal Angiogram
Clinical Study IdentifierNCT03614260
SponsorReCor Medical, Inc.
Last Modified on10 July 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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