Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)
Stopped: Study enrollment and treatment are temporarily suspended due to an FDA clinical hold. The sponsor is actively addressing the FDA's requests.
United States142 participantsStarted 2025-09-01
Plain-language summary
To obtain an assessment of the efficacy and safety of renal denervation by dehydrated alcohol injection, USP administered via the Peregrine Systemâ„¢ Infusion Catheter in hypertensive subjects in the absence of antihypertensive medications.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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).
What they're measuring
1
Changes in Systolic Ambulatory Blood Pressure at 8 weeks
✕. 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.