Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)
Paused · Phase 3 · Has a placebo group
Conditions studied: Hypertension, Hypertension,Essential
In brief
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 facts
- Study ID
- NCT07083765
- Run by
- Ablative Solutions, Inc.
- People needed
- 142
- Starts
- 2025-09-01
- Expected to finish
- 2027-10-31
- Last updated by the study team
- 2026-04-30
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has 2 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥150 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg.
- Documented history of uncontrolled hypertension and is currently taking 1 or 2 antihypertensive medications.
- Is willing to discontinue any current antihypertensive medications for at least 13 weeks (5-week pre-procedure and 8-week post-procedure).
- Has a mean 24-hour ambulatory SBP of ≥140 mmHg and ≤170 mmHg with required valid readings.
You may not qualify if…
- Has renal artery anatomy abnormalities.
- Has previously undergone renal denervation.
- Has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy.
- Has documented untreated sleep apnea.
- Has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association [NYHA] Class III or IV), chronic atrial fibrillation (defined as at least one documented episode in the 12 months before study entry), and known primary pulmonary hypertension (>60 mmHg pulmonary artery or right ventricular systolic pressure).
- Is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
- Is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed.
- Has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.
Where it is running
- Tennova Turkey Creek Medical Center — Knoxville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.