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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension, Vascular Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Device: Paradise Renal Denervation System
* Procedure: Renal Angiogram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br>Renal Angiogram and Renal Denervation (Paradise Renal Denervation System) | Device: Paradise Renal Denervation System<br>* Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.<br>* Other names: Renal Denervation;|
| Sham Comparator: Sham Control<br>Renal Angiogram | Procedure: Renal Angiogram<br>* Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Major Adverse Events (MAE) |  | From baseline to 30 days post-procedure | 
| Change in average daytime ambulatory systolic BP |  | From baseline to 2 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average 24-hr ambulatory systolic BP |  | From baseline to 2 months post-procedure | 
| Change in average office systolic BP |  | From baseline to 2 months post-procedure | 
| Change in average home systolic BP |  | From baseline to 2 months post-procedure | 
| Change in average daytime ambulatory diastolic BP |  | From baseline to 2 months post-procedure | 
| Change in average 24-hr ambulatory diastolic BP |  | From baseline to 2 months post-procedure | 
| Change in average office diastolic BP |  | From baseline to 2 months post-procedure | 
| Change in average home diastolic BP |  | From baseline to 2 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Denervation, Resistant Hypertension, Essential Hypertension, Uncontrolled Hypertension