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

Prior treatment

• 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

Other illness

• Known, uncorrected causes of secondary hypertension other than sleep apnea
• Type I diabetes mellitus or uncontrolled Type II diabetes
• Primary pulmonary hypertension

Lab values

• eGFR of \<40

Other

• Lacks appropriate renal artery anatomy for treatment
• Brachial circumference ≥ 42 cm
• Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
• Night shift workers
• Pregnant, nursing or planning to become pregnant

• 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