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The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

NCT03614260 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2025-04-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Paradise Renal Denervation System

Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

PROCEDURE

Renal Angiogram

Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.

Sponsors & Collaborators

  • ReCor Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Ajay Kirtane, MD, SM · Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation

  • Prof. Michel Azizi, MD, PhD · Professor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-14
Primary Completion
2022-12-21
Completion
2027-07-31
FDA Device
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Ireland
  • Netherlands
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03614260 on ClinicalTrials.gov