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 (RADAR)

NCT07083765 Phase 3 SUSPENDED

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.

Details

Lead sponsor	Ablative Solutions, Inc.
Phase	Phase 3
Status	SUSPENDED
Enrolment	142
Start date	2025-09-01
Completion	2027-10-31

Conditions

• Hypertension
• Hypertension,Essential

Interventions

• Dehydrated Alcohol Injection, USP
• Sham procedure

Primary outcomes

• Changes in Systolic Ambulatory Blood Pressure at 8 weeks — Baseline to 8 weeks post-treatment
  Change from baseline in mean 24-hour ambulatory systolic blood pressure

Countries

United States