Cardiovascular Diseases, Hypertension, Hypertension, Resistant to Conventional Therapy, Vascular Diseases
Conditions
Keywords
Blood Pressure, Uncontrolled Hypertension, Essential Hypertension, Resistant Hypertension, Denervation
Brief summary
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.
Interventions
DEVICERenal Denervation
Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System)
Sponsors
ReCor Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Change in average office 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 systolic BP | From baseline to 2 months post procedure |
| Change in average 24-hr/night-time ambulatory diastolic BP | From baseline to Months 2, 6, and 12 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 daytime/24-hr/night-time ambulatory systolic BP | From Baseline to Months 6 and 12 post procedure |
Countries
United States
Outcome results
None listed