Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)
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
Ablative Solutions, Inc.
142 participants
Sep 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria8
- 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.
Interventions
Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
Endovascular, renal angiography
Locations(1)
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NCT07083765