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



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:3/17/2019
Start Date:December 14, 2018
End Date:October 2024
Contact:Helen Reeve-Stoffer, PhD
Email:hreeve-stoffer@recormedical.com
Phone:+44 7947 748006

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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.


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
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