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Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)

NCT07083765 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dehydrated Alcohol Injection, USP

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

PROCEDURE

Sham procedure

Endovascular, renal angiography

Sponsors & Collaborators

  • Ablative Solutions, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Weber, MD · SUNY Downstate Medical Center and College of Medicine

  • David Kandzari, MD · Piedmont Healthcare

  • Felix Mahfoud, Prof.Dr. med · University of Basel

  • Atul Pathak, Prof. · Princess Grace Hospital, Monaco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-06-30
Completion
2027-10-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

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 NCT07083765 on ClinicalTrials.gov