RecruitingPhase 3NCT07083765

Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)

A Prospective Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation Using the Dehydrated Alcohol Injection, USP Administered With the Peregrine System™ Infusion Catheter in Subjects With Hypertension, in the Absence of Antihypertensive Medications


Sponsor

Ablative Solutions, Inc.

Enrollment

142 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To obtain an assessment of the efficacy and safety of renal denervation by dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter in hypertensive subjects in the absence of antihypertensive medications.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a minimally invasive procedure called renal artery denervation (RDN) to lower blood pressure. The procedure uses a catheter to gently disrupt nerves around the kidney arteries that contribute to high blood pressure, potentially reducing the long-term need for medications. **You may be eligible if...** - Your blood pressure remains high (systolic at or above 150 mmHg) despite taking 1 or 2 blood pressure medications - Your 24-hour blood pressure monitoring also shows elevated readings - You are willing to temporarily stop your blood pressure medications for about 13 weeks during the study **You may NOT be eligible if...** - You have abnormal kidney artery anatomy - You have already had a renal denervation procedure - Your kidney function is significantly reduced - You have other serious conditions affecting the kidneys, heart, or blood vessels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDehydrated Alcohol Injection, USP

Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries

PROCEDURESham procedure

Endovascular, renal angiography


Locations(1)

Tennova Turkey Creek Medical Center

Knoxville, Tennessee, United States

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NCT07083765


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