NCT05017935Active, not recruiting
RADIANCE Continued Access Protocol
RADIANCE Continued Access Protocol (RADIANCE CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension
Source: ClinicalTrials.gov · Last updated 17 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 17 Aug 2021
- Start date
- 4 May 2022
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- ReCor Medical, Inc.
- Diseases
- High blood pressure
- NCT number
- NCT05017935
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 4 May 2022 to the primary completion date, 31 Dec 2028
- 40 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Secondary hypertension not including sleep apnea
- Primary pulmonary hypertension
Lab values
- Type I diabetes mellitus or uncontrolled Type II diabetes (defined as plasma HbA1c ≥9.0%)
- eGFR \<40
Other
- Renal artery anatomy ineligible for treatment
- Brachial circumference ≥42 cm
- Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
- Night shift workers
- Pregnant, nursing or planning to become pregnant
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Lifebridge Health Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| The Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Bridgeport Hospital Coordinator of this site? Confirm its status | Bridgeport | United States | Unknown status |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cardiovascular Institute of San Diego Coordinator of this site? Confirm its status | Chula Vista | United States | Unknown status |
| UnityPoint Health-Des Moines Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Parkview Research Center Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| The Cardiac and Vascular Institute Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Cone Health Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Cardiovascular Associates of the Delaware Valley Coordinator of this site? Confirm its status | Haddon Heights | United States | Unknown status |
| The University of Texas Health Sciences Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Saint Luke's Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Texas Tech University Health Sciences Center Coordinator of this site? Confirm its status | Lubbock | United States | Unknown status |
| Baptist Hospital of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| NYU Langone Hospital - Long Island Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| Ochsner Medical Center Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Columbia University Medical Center/NYPH Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Orlando Health Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Penn Medicine Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| UPMC Heart and Vascular Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| NJ Heart & Vascular Coordinator of this site? Confirm its status | Princeton | United States | Unknown status |
| Renown Regional Medical Center Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Sutter Health Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Tidal Health Coordinator of this site? Confirm its status | Salisbury | United States | Unknown status |
| University of Texas Health Sciences Center, San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Pacific Heart Institute Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
| Swedish Health Services Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| SIU Medicine Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Prairie Education And Research Cooperative Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Stony Brook University Hospital Coordinator of this site? Confirm its status | Stony Brook | United States | Unknown status |
| Baylor Scott & White Research Institute Coordinator of this site? Confirm its status | Temple | United States | Unknown status |
| St. Francis Hospital Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| Umass Memorial Medical Center Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.