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

NCT03614260 | Active Not Recruiting FDA Device

• 1 other identifier: RADIANCE II Study
• Study Type: interventional
• Target: 225
• Locations: 8 countries
• Sites: 47

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.

Conditions

Hypertension; Vascular Diseases; Cardiovascular Diseases

Keywords

Denervation; Resistant Hypertension; Essential Hypertension; Uncontrolled Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change in average 24-hr ambulatory systolic BP

  From baseline to 2 months post-procedure

• Change in average office systolic BP

  From baseline to 2 months post-procedure

• 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 diastolic BP

  From baseline to 2 months post-procedure

Study Arms (2)

Renal Denervation

EXPERIMENTAL

Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)

Device: Paradise Renal Denervation System

Sham Control

SHAM COMPARATOR

Renal Angiogram

Procedure: Renal Angiogram

Interventions

Paradise Renal Denervation System DEVICE

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

Also known as: Renal Angiogram, Renal Denervation

Renal Denervation

Renal Angiogram PROCEDURE

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

Sham Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ReCor Medical, Inc.: lead

Study Sites (47)

Cardiology PC

Birmingham, Alabama, 35211, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 940048, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Stamford Hospital

Stamford, Connecticut, 06904, United States

Location

MedStar Washington

Washington D.C., District of Columbia, 20010, United States

Location

The Cardiac and Vascular Institute

Gainesville, Florida, 32605, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Southern Illinois University

Springfield, Illinois, 62794, United States

Location

Ochsner Heart and Vascular Institute

New Orleans, Louisiana, 70121, United States

Location

The Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Saint Luke's Health System

Kansas City, Missouri, 64111, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Deborah Heart & Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Hackensack University

Hackensack, New Jersey, 07601, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

Northwell Health Inc.

New York, New York, 10075, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

The University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Centre Hospitalier Universitaire Saint-Pierre

Brussels, 1000, Belgium

Location

Hôpital Saint André

Bordeaux, 33000, France

Location

CHRU de Lille

Lille, 59000, France

Location

Hôpital Européen Georges-Pompidou (HEGP)

Paris, 75015, France

Location

University Clinic Erlangen

Erlangen, D-91054, Germany

Location

University Clinic of Saarland - Homburg

Homburg, D-66421, Germany

Location

Klinikum Karlsruhe GmbH

Karlsruhe, 76133, Germany

Location

Klinikum Konstanz

Konstanz, D-78464, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, D-04289, Germany

Location

Sana Kliniken Lübeck GmbH

Lübeck, D-23560, Germany

Location

University Hospital Galway

Galway, H91 YR71, Ireland

Location

Erasmus Medical Center

Rotterdam, 3015 GD, Netherlands

Location

Hôpitaux Universitaires Genève

Geneva, 1211, Switzerland

Location

The Cardiothoracic Centre Basildon University Hospital

Basildon, Essex, SS16 5NL, United Kingdom

Location

University Hospitals Dorset NHS Foundation Trust

Bournemouth, BH7 7DW, United Kingdom

Location

Kent & Canterbury Hospital

Canterbury, CT1 3NG, United Kingdom

Location

University Hospital Wales

Cardiff, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (3)

• Azizi M, Saxena M, Wang Y, Jenkins JS, Devireddy C, Rader F, Fisher NDL, Schmieder RE, Mahfoud F, Lindsey J, Sanghvi K, Todoran TM, Pacella J, Flack J, Daemen J, Sharp ASP, Lurz P, Bloch MJ, Weber MA, Lobo MD, Basile J, Claude L, Reeve-Stoffer H, McClure CK, Kirtane AJ; RADIANCE II Investigators and Collaborators. Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial. JAMA. 2023 Feb 28;329(8):651-661. doi: 10.1001/jama.2023.0713.

  PMID: 36853250 RESULT

• Azizi M, Sharp ASP, Fisher NDL, Weber MA, Lobo MD, Daemen J, Lurz P, Mahfoud F, Schmieder RE, Basile J, Bloch MJ, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Claude L, Augustin DA, McClure CK, Kirtane AJ; RADIANCE Investigators. Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program. Circulation. 2024 Mar 5;149(10):747-759. doi: 10.1161/CIRCULATIONAHA.123.066941. Epub 2023 Oct 26.

  PMID: 37883784 DERIVED

• Kirtane AJ, Sharp ASP, Mahfoud F, Fisher NDL, Schmieder RE, Daemen J, Lobo MD, Lurz P, Basile J, Bloch MJ, Weber MA, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Sapoval M, Barman NC, Claude L, Augustin D, Thackeray L, Mullin CM, Azizi M; RADIANCE Investigators and Collaborators. Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials. JAMA Cardiol. 2023 May 1;8(5):464-473. doi: 10.1001/jamacardio.2023.0338.

  PMID: 36853627 DERIVED

MeSH Terms

Conditions

Hypertension; Vascular Diseases; Cardiovascular Diseases; Essential Hypertension

Study Officials

• Ajay Kirtane, MD, SM

  Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation

  PRINCIPAL INVESTIGATOR

• Prof. Michel Azizi, MD, PhD

  Professor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: December 14, 2018
• Primary Completion: December 21, 2022
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

US (28); IE (1); NL (1); CH (1); BE (1); FR (3); DE (6); GB (6)