RADIANCE II Pivotal Study: En undersøgelse af ReCor Medical Paradise System i fase II hypertension (RADIANCE-II)
23. september 2026 opdateret af: ReCor Medical, Inc.
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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
224
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Brussels, Belgien, 1000
- Centre Hospitalier Universitaire Saint-Pierre
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Bournemouth, Det Forenede Kongerige, BH7 7DW
- University Hospitals Dorset NHS Foundation Trust
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Canterbury, Det Forenede Kongerige, CT1 3NG
- Kent & Canterbury Hospital
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Cardiff, Det Forenede Kongerige
- University Hospital Wales
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London, Det Forenede Kongerige, EC1A 7BE
- St Bartholomew's Hospital
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Newcastle upon Tyne, Det Forenede Kongerige, NE7 7DN
- Freeman Hospital
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Essex
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Basildon, Essex, Det Forenede Kongerige, SS16 5NL
- The Cardiothoracic Centre Basildon University Hospital
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Alabama
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Birmingham, Alabama, Forenede Stater, 35211
- Cardiology PC
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California
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Los Angeles, California, Forenede Stater, 940048
- Cedars Sinai Medical Center
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Connecticut
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Bridgeport, Connecticut, Forenede Stater, 06610
- Bridgeport Hospital
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Stamford, Connecticut, Forenede Stater, 06904
- Stamford Hospital
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20010
- MedStar Washington
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Florida
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Gainsville, Florida, Forenede Stater, 32605
- The Cardiac and Vascular Institute
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Georgia
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Atlanta, Georgia, Forenede Stater, 30308
- Emory University Hospital Midtown
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
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Springfield, Illinois, Forenede Stater, 62794
- Southern Illinois University
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Heart and Vascular Institute
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02120
- The Brigham and Women's Hospital
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Michigan
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Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55407
- Minneapolis Heart Institute Foundation
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Missouri
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Kansas City, Missouri, Forenede Stater, 64111
- Saint Luke's Health System
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Nevada
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Reno, Nevada, Forenede Stater, 89502
- Renown Regional Medical Center
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New Jersey
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Browns Mills, New Jersey, Forenede Stater, 08015
- Deborah Heart & Lung Center
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Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University
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New York
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New York, New York, Forenede Stater, 10032
- Columbia University Medical Center/NYPH
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New York, New York, Forenede Stater, 10075
- Northwell Health Inc.
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- The University of North Carolina at Chapel Hill
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania Health System
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh Medical Center
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38163
- The University of Tennessee Health Science Center
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University
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Utah
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Salt Lake City, Utah, Forenede Stater, 84132
- University of Utah
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Washington
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Seattle, Washington, Forenede Stater, 98122
- Swedish Medical Center
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Bordeaux, Frankrig, 33000
- Hôpital Saint André
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Lille, Frankrig, 59000
- CHRU de Lille
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Paris, Frankrig, 75015
- Hôpital Européen Georges-Pompidou (HEGP)
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Rotterdam, Holland, 3015 GD
- Erasmus Medical Center
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Galway, Irland, H91 YR71
- University Hospital Galway
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Geneva, Schweiz, 1211
- Hôpitaux Universitaires Genève
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Erlangen, Tyskland, D-91054
- University Clinic Erlangen
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Homburg, Tyskland, D-66421
- University Clinic of Saarland - Homburg
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Karlsruhe, Tyskland, 76133
- Klinikum Karlsruhe GmbH
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Konstanz, Tyskland, D-78464
- Klinikum Konstanz
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Leipzig, Tyskland, D-04289
- Herzzentrum Leipzig GmbH
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Lübeck, Tyskland, D-23560
- Sana Kliniken Lübeck GmbH
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Renal Denervation
Renal Angiogram and Renal Denervation (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.
Andre navne:
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Sham-komparator: Sham Control
Renal Angiogram |
Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Average Daytime Ambulatory Systolic BP
Tidsramme: From baseline to 2 months post-procedure
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The primary efficacy outcome is the mean change in daytime ambulatory systolic blood pressure at 2 months |
From baseline to 2 months post-procedure
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Percentage of Participants With Major Adverse Events (MAE)
Tidsramme: From baseline to 30 days post-procedure
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The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular, and hypertensive events at 30 days. |
From baseline to 30 days post-procedure
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Average 24-hr Ambulatory Systolic BP
Tidsramme: From baseline to 2 months post-procedure
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Change in average 24-hr ambulatory systolic blood pressure |
From baseline to 2 months post-procedure
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Change in Average Office Systolic BP
Tidsramme: From baseline to 2 months post-procedure
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Change in average office systolic blood pressure |
From baseline to 2 months post-procedure
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Change in Average Home Systolic BP
Tidsramme: From baseline to 2 months post-procedure
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Change in average home systolic blood pressure |
From baseline to 2 months post-procedure
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Change in Average Daytime Ambulatory Diastolic BP
Tidsramme: From baseline to 2 months post-procedure
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Change in average daytime ambulatory diastolic blood pressure |
From baseline to 2 months post-procedure
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Change in Average 24-hr Ambulatory Diastolic BP
Tidsramme: From baseline to 2 months post-procedure
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Change in average 24-hr ambulatory diastolic blood pressure |
From baseline to 2 months post-procedure
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Change in Average Office Diastolic BP
Tidsramme: From baseline to 2 months post-procedure
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Change in average office diastolic blood pressure |
From baseline to 2 months post-procedure
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Change in Average Home Diastolic BP
Tidsramme: From baseline to 2 months post-procedure
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Change in average home diastolic blood pressure |
From baseline to 2 months post-procedure
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ajay Kirtane, MD, SM, Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation
- Ledende efterforsker: Prof. Michel Azizi, MD, PhD, Professor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- Bytyqi V, Kannenkeril D, Striepe K, Bosch A, Karg MV, Schmid A, Schiffer M, Uder M, Schmieder RE. Predicting blood pressure response to renal denervation based on a new approach. J Hypertens. 2025 Mar 1;43(3):413-419. doi: 10.1097/HJH.0000000000003918. Epub 2024 Oct 29.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. december 2018
Primær færdiggørelse (Faktiske)
21. december 2022
Studieafslutning (Anslået)
1. juli 2029
Datoer for studieregistrering
Først indsendt
30. juli 2018
Først indsendt, der opfyldte QC-kriterier
30. juli 2018
Først opslået (Faktiske)
3. august 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RADIANCE II Study
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .