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

ReCor Medical

Status

Active, not recruiting

Conditions

Hypertension

Cardiovascular Diseases

Vascular Diseases

Treatments

Procedure: Renal Angiogram

Device: Paradise Renal Denervation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03614260

RADIANCE II Study

Details and patient eligibility

About

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.

Enrollment

225 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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