Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor: Ablative Solutions, Inc.
Study ID: NCT07083765
Phase: PHASE3
Status: Not Yet Recruiting

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Conditions

Hypertension
Hypertension,Essential

Eligibility Criteria

Sex: ALL
Age: 18 Years - 80 Years
Healthy Volunteers: Not accepted

Interventions

Dehydrated Alcohol Injection, USP — DRUG
Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
Sham procedure — PROCEDURE
Endovascular, renal angiography

Study Details

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.

Key Dates

First listed: Jul 24, 2025
Start date: Oct 31, 2026
Status verified: Aug 2026
Primary completion: May 31, 2028
Completion: Feb 28, 2029

Study Design

Enrollment: 202 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Treatment Arm
Renal denervation performed with dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter.
Sham Comparator: Sham Control Arm
Only renal angiography performed