RADIANCE Continued Access Protocol

Study Overview
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Brief Summary
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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.

Official Title
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RADIANCE Continued Access Protocol (RADIANCE CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension

Conditions
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Hypertension, Hypertension, Resistant to Conventional Therapy, Vascular Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Device: Renal Denervation


Participation Criteria
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Eligibility Criteria
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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

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br> | Device: Renal Denervation<br>* Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events |  | From baseline to 60 months | 
| 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/night-time ambulatory systolic BP |  | From baseline to 2 months post procedure | 
| Change in average daytime/24-hr/night-time ambulatory systolic BP |  | From Baseline to Months 6 and 12 post procedure | 
| Change in average office systolic/diastolic BP |  | From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure | 
| Change in average home systolic/diastolic BP |  | From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure | 
| Change in average 24-hr/night-time ambulatory diastolic BP |  | From baseline to Months 2, 6, and 12 post procedure | 

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