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

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ClinicalTrials.gov Identifier: NCT03614260

Recruitment Status : Recruiting

First Posted : August 3, 2018

Last Update Posted : December 4, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

ReCor Medical, Inc.

Tracking Information

First Submitted Date ^ICMJE

July 30, 2018

First Posted Date ^ICMJE

August 3, 2018

Last Update Posted Date

December 4, 2020

Actual Study Start Date ^ICMJE

December 14, 2018

Estimated Primary Completion Date

February 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Incidence of Major Adverse Events (MAE) [ Time Frame: From baseline to 30 days post-procedure ]
Reduction in average daytime ambulatory systolic BP [ Time Frame: From baseline to 2 months post-procedure ]

Change History

Current Secondary Outcome Measures ^ICMJE

Change in average 24-hr ambulatory systolic BP [ Time Frame: From baseline to 2 months post-procedure ]
Change in average office systolic BP [ Time Frame: From baseline to 2 months post-procedure ]
Change in average home systolic BP [ Time Frame: From baseline to 2 months post-procedure ]
Change in average daytime ambulatory diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]
Change in average 24-hr ambulatory diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]
Change in average office diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]
Change in average home diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]

Original Secondary Outcome Measures ^ICMJE

Reduction in average 24-hr ambulatory systolic BP [ Time Frame: From baseline to 2 months post-procedure ]
Reduction in average office systolic BP [ Time Frame: From baseline to 2 months post-procedure ]
Reduction in average home systolic BP [ Time Frame: From baseline to 2 months post-procedure ]
Reduction in average daytime ambulatory diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]
Reduction in average 24-hr ambulatory diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]
Reduction in average office diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]
Reduction in average home diastolic BP [ Time Frame: From baseline to 2 months post-procedure ]

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension
Vascular Diseases
Cardiovascular Diseases

Intervention ^ICMJE

Device: Paradise Renal Denervation System
Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
Other Names:
- Renal Angiogram
- Renal Denervation
Procedure: Renal Angiogram
Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.

Study Arms ^ICMJE

Experimental: Renal Denervation
Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)

Intervention: Device: Paradise Renal Denervation System
Sham Comparator: Sham Control
Renal Angiogram

Intervention: Procedure: Renal Angiogram

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

225

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

December 2026

Estimated Primary Completion Date

February 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 75 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Helen Reeve-Stoffer, PhD	+44 7947 748006	hreeve-stoffer@recormedical.com
Contact: Tracy Rodriguez	+1 650 542 7721	trodriguez@recormedical.com

Listed Location Countries ^ICMJE

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

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT03614260

Other Study ID Numbers ^ICMJE

RADIANCE II Study

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	Yes
Device Product Not Approved or Cleared by U.S. FDA:	Yes

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

ReCor Medical, Inc.

Study Sponsor ^ICMJE

ReCor Medical, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	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

PRS Account

ReCor Medical, Inc.

Verification Date

December 2020

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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