RADIANCE Continued Access Protocol

NCT ID: NCT05017935

Last Updated: 2024-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-04

Study Completion Date

2028-12-31

Brief Summary

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RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.

Detailed Description

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Conditions

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Hypertension Hypertension, Resistant to Conventional Therapy Vascular Diseases Cardiovascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Renal Denervation

Group Type EXPERIMENTAL

Renal Denervation

Intervention Type DEVICE

Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System)

Interventions

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Renal Denervation

Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Average office BP ≥140/90 mmHg at screening visit despite taking stables doses of antihypertensive medications for at least 4 weeks prior to consent
* Documented daytime ABP ≥135/85 mmHg following 4 week run-in/standardization period on antihypertensive medication regimen

Exclusion Criteria

* Renal artery anatomy ineligible for treatment
* Secondary hypertension not including sleep apnea
* Type I diabetes mellitus or uncontrolled Type II diabetes (defined as plasma HbA1c ≥9.0%)
* eGFR \<40
* Brachial circumference ≥42 cm
* Any history of cerebrovascular event or severe cardiovascular event within 3 months prior to consent
* Documented repeat (\>1) hospitalization for hypertensive crisis within 3 months prior to consent
* Documented confirmed episode(s) of unstable angina within 3 months prior to consent
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ReCor Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naomi Fisher, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital/Harvard Medical School

Ajay Kirtane, MD, SM

Role: PRINCIPAL_INVESTIGATOR

Columbia University Medical Center/NYPH

Locations

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Cardiovascular Institute of San Diego

Chula Vista, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Sutter Health

Sacramento, California, United States

Site Status

Pacific Heart Institute

Santa Monica, California, United States

Site Status

Bridgeport Hospital

Bridgeport, Connecticut, United States

Site Status

The Cardiac and Vascular Institute

Gainesville, Florida, United States

Site Status

Baptist Hospital of Miami

Miami, Florida, United States

Site Status

Orlando Health

Orlando, Florida, United States

Site Status

Emory

Atlanta, Georgia, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Prairie Education and Research Cooperative

Springfield, Illinois, United States

Site Status

SIU Medicine

Springfield, Illinois, United States

Site Status

Parkview Research Center

Fort Wayne, Indiana, United States

Site Status

UnityPoint Health-Des Moines

Des Moines, Iowa, United States

Site Status

Ochsner Medical Center

New Orleans, Louisiana, United States

Site Status

Lifebridge Health

Baltimore, Maryland, United States

Site Status

Tidal Health

Salisbury, Maryland, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

The Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

UMASS Memorial Medical Center

Worcester, Massachusetts, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Saint Luke's Hospital

Kansas City, Missouri, United States

Site Status

Renown Regional Medical Center

Reno, Nevada, United States

Site Status

Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, United States

Site Status

NJ Heart & Vascular

Princeton, New Jersey, United States

Site Status

NYU Langone Hospital - Long Island

Mineola, New York, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

Columbia University Medical Center/NYPH

New York, New York, United States

Site Status

Stony Brook University Hospital

Stony Brook, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Cone Health

Greensboro, North Carolina, United States

Site Status

St. Francis Hospital

Tulsa, Oklahoma, United States

Site Status

Penn Medicine

Philadelphia, Pennsylvania, United States

Site Status

UPMC Heart and Vascular Center

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

The University of Texas Health Sciences Center at Houston

Houston, Texas, United States

Site Status

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

Site Status

University of Texas Health Sciences Center, San Antonio

San Antonio, Texas, United States

Site Status

Baylor Scott & White Research Institute

Temple, Texas, United States

Site Status

Swedish Health Services

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Azizi M, Sanghvi K, Saxena M, Gosse P, Reilly JP, Levy T, Rump LC, Persu A, Basile J, Bloch MJ, Daemen J, Lobo MD, Mahfoud F, Schmieder RE, Sharp ASP, Weber MA, Sapoval M, Fong P, Pathak A, Lantelme P, Hsi D, Bangalore S, Witkowski A, Weil J, Kably B, Barman NC, Reeve-Stoffer H, Coleman L, McClure CK, Kirtane AJ; RADIANCE-HTN investigators. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet. 2021 Jun 26;397(10293):2476-2486. doi: 10.1016/S0140-6736(21)00788-1. Epub 2021 May 16.

Reference Type BACKGROUND
PMID: 34010611 (View on PubMed)

Related Links

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https://www.recormedical.com/

ReCor Medical company website

Other Identifiers

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CLN-0932

Identifier Type: -

Identifier Source: org_study_id

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