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

Conditions

Cardiovascular Diseases, Hypertension, Vascular Diseases

Keywords

Denervation, Resistant Hypertension, Essential Hypertension, Uncontrolled Hypertension

Brief summary

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.

Michel Azizi, Andrew Sharp, Naomi D.L. Fisher, Michael A. Weber, Melvin D. Lobo et al. (100 authors)

Circulation2023-10-2632 citations

10.1161/circulationaha.123.066941

Endovascular Ultrasound Renal Denervation to Treat Hypertension

Michel Azizi, Manish Saxena, Yale Wang, J. Stephen Jenkins, Chandan Devireddy et al. (100 authors)

JAMA2023-02-28163 citations

10.1001/jama.2023.0713

Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials

Ajay J. Kirtane, Andrew Sharp, Felix Mahfoud, Naomi D.L. Fisher, Roland E. Schmieder et al. (100 authors)

JAMA Cardiology2023-02-2877 citations

10.1001/jamacardio.2023.0338

Interventions

DEVICEParadise Renal Denervation System

Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

PROCEDURERenal Angiogram

Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Incidence of Major Adverse Events (MAE)	From baseline to 30 days post-procedure
Change in average daytime ambulatory systolic BP	From baseline to 2 months post-procedure

Secondary

Measure	Time frame
Change in average home systolic BP	From baseline to 2 months post-procedure
Change in average daytime ambulatory diastolic BP	From baseline to 2 months post-procedure
Change in average 24-hr ambulatory systolic BP	From baseline to 2 months post-procedure
Change in average office diastolic BP	From baseline to 2 months post-procedure
Change in average home diastolic BP	From baseline to 2 months post-procedure
Change in average 24-hr ambulatory diastolic BP	From baseline to 2 months post-procedure
Change in average office systolic BP	From baseline to 2 months post-procedure

Countries

Belgium, France, Germany, Ireland, Netherlands, Switzerland, United Kingdom, United States

Outcome results

None listed