drugset / Trial / NCT07083765

Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)

NCT07083765 ↗

Phase 3 Suspended 142 enrolled Ablative Solutions, Inc.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-09-01
Primary completion
2027-06
Completion
2027-10-31

Outcome

Outcome not reported

Stopped (Enrollment): “Study enrollment and treatment are temporarily suspended due to an FDA clinical hold. The sponsor is actively addressing the FDA's requests.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Dehydrated Alcohol Injection, USP Unknown — Other