The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension (NCT03614260) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
United States225 participantsStarted 2018-12-14
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
What they're measuring
1
Incidence of Major Adverse Events (MAE)
Timeframe: From baseline to 30 days post-procedure
2
Change in average daytime ambulatory systolic BP
Timeframe: From baseline to 2 months post-procedure