The RADIANCE CED Study
The Recor Paradise System™ Hypertension Coverage With Evidence Development Study
1 other identifier
observational
1,000
1 country
1
Brief Summary
The RADIANCE CED study is a prospective observational study designed to evaluate the long-term effectiveness of ultrasound renal denervation in lowering blood pressure among patients with uncontrolled hypertension. Data will be collected from electronic health records (EHRs) of Medicare-eligible patients to support generalizability of outcomes to the broader Medicare population. Individual hospital enrollment is not required for this study and IRB exemption has been received by sponsor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2025
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2025
CompletedFirst Posted
Study publicly available on registry
November 17, 2025
CompletedStudy Start
First participant enrolled
November 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
January 9, 2026
January 1, 2026
4.1 years
September 15, 2025
January 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment for Changes in Blood Pressure
November 2025 - December 2029
Secondary Outcomes (2)
Occurrence of Adverse Cardiovascular and Cerebrovascular Event
November 2025 - December 2029
Changes in Anti-Hypertensive Medication
November 2025 - December 2029
Study Arms (2)
Exposure Group (uRDN + SOC)
A procedure or device code for the Paradise™ ultrasound renal denervation system (uRDN) and medication records indicating receipt of blood pressure-lowering medications.
Comparator Group (SOC)
Medication records indicating receipt of blood pressure-lowering medications.
Interventions
A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.
Eligibility Criteria
Adults aged ≥ 65 years with uncontrolled hypertension
You may qualify if:
- Adults aged ≥65 years with uncontrolled hypertension
- Stable regimen of blood pressure-lowering medication
You may not qualify if:
- Hypertension due to secondary causes
- Prior renal denervation treatment
- Pregnancy
- End-stage renal disease, dialysis, or kidney transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henry Ford St. John Hospital
Detroit, Michigan, 48236, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Megan Coylewright, MD
Essentia Health
- PRINCIPAL INVESTIGATOR
Amir Kaki, MD
Ascension St. John Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2025
First Posted
November 17, 2025
Study Start
November 21, 2025
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2031
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
There is no plan to make individual participant data (IPD) available.