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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation | Experimental | Renal Angiogram and Renal Denervation (Paradise Renal Denervation System) |
|
| Sham Control | Sham Comparator | Renal Angiogram |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology PC | Birmingham | Alabama | 35211 | United States | ||
| Cedars Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36853250 | Result | 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. | |
| 37883784 |
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|
| Renal Angiogram | Procedure | Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham 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 |
| 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 |
| Los Angeles |
| California |
| 940048 |
| United States |
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States |
| Stamford Hospital | Stamford | Connecticut | 06904 | United States |
| MedStar Washington | Washington D.C. | District of Columbia | 20010 | United States |
| The Cardiac and Vascular Institute | Gainesville | Florida | 32605 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Southern Illinois University | Springfield | Illinois | 62794 | United States |
| Ochsner Heart and Vascular Institute | New Orleans | Louisiana | 70121 | United States |
| The Brigham and Women's Hospital | Boston | Massachusetts | 02120 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| Saint Luke's Health System | Kansas City | Missouri | 64111 | United States |
| Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| Deborah Heart & Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Hackensack University | Hackensack | New Jersey | 07601 | United States |
| Columbia University Medical Center/NYPH | New York | New York | 10032 | United States |
| Northwell Health Inc. | New York | New York | 10075 | United States |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| The University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Centre Hospitalier Universitaire Saint-Pierre | Brussels | 1000 | Belgium |
| Hôpital Saint André | Bordeaux | 33000 | France |
| CHRU de Lille | Lille | 59000 | France |
| Hôpital Européen Georges-Pompidou (HEGP) | Paris | 75015 | France |
| University Clinic Erlangen | Erlangen | D-91054 | Germany |
| University Clinic of Saarland - Homburg | Homburg | D-66421 | Germany |
| Klinikum Karlsruhe GmbH | Karlsruhe | 76133 | Germany |
| Klinikum Konstanz | Konstanz | D-78464 | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | D-04289 | Germany |
| Sana Kliniken Lübeck GmbH | Lübeck | D-23560 | Germany |
| University Hospital Galway | Galway | H91 YR71 | Ireland |
| Erasmus Medical Center | Rotterdam | 3015 GD | Netherlands |
| Hôpitaux Universitaires Genève | Geneva | 1211 | Switzerland |
| The Cardiothoracic Centre Basildon University Hospital | Basildon | Essex | SS16 5NL | United Kingdom |
| University Hospitals Dorset NHS Foundation Trust | Bournemouth | BH7 7DW | United Kingdom |
| Kent & Canterbury Hospital | Canterbury | CT1 3NG | United Kingdom |
| University Hospital Wales | Cardiff | United Kingdom |
| St Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Derived |
| 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. |
| 36853627 | 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. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000075222 | Essential Hypertension |
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