Tests an alcohol injection in kidney nerves for adults with high blood pressure
Tests an alcohol injection into kidney nerves in adults with high blood pressure.
Plain-language title generated from the registry record
Registry title: Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)
Key facts
- Where
- Knoxville, United StatesSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07083765, who can take part
Where in United States
- Tennova Turkey Creek Medical CenterKnoxville, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ablative Solutions, Inc.
- Trial code
- NCT07083765
- Record updated
- 20 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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 0, 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: Has previously undergone renal denervation; 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 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; 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 renal artery anatomy abnormalities; Has documented untreated sleep apnea; Is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).