NCT05017935Active, not recruitingNot Applicable
RADIANCE Continued Access Protocol (RADIANCE CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ReCor Medical, Inc.
- Enrollment
- 300
- Locations
- 80
- Primary Endpoint
- Incidence of Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Incidence of Adverse Events
Time Frame: From baseline to 60 months
Change in average daytime ambulatory systolic BP
Time Frame: From baseline to 2 months post procedure
Secondary Outcomes
- Change in average daytime/24-hr/night-time ambulatory systolic BP(From Baseline to Months 6 and 12 post procedure)
- Change in average 24-hr/night-time ambulatory systolic BP(From baseline to 2 months 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)
- Change in average office systolic/diastolic BP(From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure)
Investigators
Study Sites (80)
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