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Renal Denervation System

Renal Denervation for High Blood Pressure (RADIANCE-II Trial)

N/A

Waitlist Available

Led By Ajay Kirtane, MD, SM

Research Sponsored by ReCor Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previously or currently prescribed antihypertensive therapy

Be older than 18 years old

Must not have

Primary pulmonary hypertension

Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing whether the Paradise System, a new treatment for hypertension, is effective and safe. The trial will enroll people who have Stage 2 hypertension and are not currently taking any medication for their hypertension.

Who is the study for?

This trial is for adults with Stage II hypertension, who have been on 0-2 blood pressure medications. They should have a documented high blood pressure range and can't be on chronic oxygen support or have severe cardiovascular issues. Pregnant individuals or those with uncontrolled diabetes are excluded.

What is being tested?

The study tests the Paradise System's safety and effectiveness in lowering blood pressure compared to a renal angiogram procedure. Participants will either receive the Paradise treatment or undergo an angiogram without denervation.

What are the potential side effects?

Potential side effects may include discomfort at the catheter insertion site, bruising, bleeding, kidney artery damage, elevated blood pressure post-procedure, and possible impacts on kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been prescribed medication for high blood pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have high blood pressure in the lungs.

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I need oxygen or a ventilator during the day, not just for sleep apnea at night.

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My kidney arteries are not suitable for treatment.

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I have Type I diabetes or my Type II diabetes is not under control.

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My kidney function is low.

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I have high blood pressure not caused by sleep apnea or treated conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Renal DenervationExperimental Treatment1 Intervention

Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)

Group II: Sham ControlPlacebo Group1 Intervention

Renal Angiogram

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

ReCor Medical, Inc.Lead Sponsor

10 Previous Clinical Trials

4,941 Total Patients Enrolled

Ajay Kirtane, MD, SMPrincipal InvestigatorColumbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation

2 Previous Clinical Trials

2,305 Total Patients Enrolled

Prof. Michel Azizi, MD, PhDPrincipal InvestigatorProfessor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou