The RADIANCE CED Study

NCT ID: NCT07231757

Last Updated: 2026-01-09

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

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-21

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Cardiovascular Diseases Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)

Intervention Type DEVICE

A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.

Comparator Group (SOC)

Medication records indicating receipt of blood pressure-lowering medications.

No interventions assigned to this group

Interventions

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Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)

A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.

Intervention Type DEVICE

Other Intervention Names

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Paradise™ ultrasound renal denervation system

Eligibility Criteria

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Inclusion Criteria

* Adults aged ≥65 years with uncontrolled hypertension
* Stable regimen of blood pressure-lowering medication

Exclusion Criteria

* Hypertension due to secondary causes
* Prior renal denervation treatment
* Pregnancy
* End-stage renal disease, dialysis, or kidney transplant
Minimum Eligible Age

65 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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Megan Coylewright, MD

Role: PRINCIPAL_INVESTIGATOR

Essentia Health

Amir Kaki, MD

Role: PRINCIPAL_INVESTIGATOR

Ascension St. John Hospital

Locations

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Henry Ford St. John Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Helen Reeve-Stoffer, Ph.D

Role: CONTACT

650-542-7700

Elizabeth A Sheehan, MLIS, MA

Role: CONTACT

650-542-7700

Facility Contacts

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Amir Kaki, MD

Role: primary

Other Identifiers

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RADIANCE CED

Identifier Type: -

Identifier Source: org_study_id

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