The RADIANCE CED Study

ReCor Medical, Inc.1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Interventions

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

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Common Inclusion Criteria: * Adults aged ≥65 years with uncontrolled hypertension * Stable regimen of blood pressure-lowering medication Common Exclusion Criteria: * Hypertension due to secondary causes * Prior renal denervation treatment * Pregnancy * End-stage renal disease, dialysis, or kidney transplant

Locations (1)

Henry Ford St. John Hospital

Detroit, Michigan, United States

RECRUITING

Outcomes

Primary Outcomes

Assessment for Changes in Blood Pressure

Time frame: November 2025 - December 2029

Secondary Outcomes

Occurrence of Adverse Cardiovascular and Cerebrovascular Event

Time frame: November 2025 - December 2029

Changes in Anti-Hypertensive Medication

Time frame: November 2025 - December 2029

Central Contacts

Helen Reeve-Stoffer, Ph.D

CONTACT

650-542-7700 hreeve-stoffer@recormedical.com

Elizabeth A Sheehan, MLIS, MA

CONTACT

650-542-7700 liz.sheehan@recormedical.com

Data from ClinicalTrials.gov

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