NCT07083765Not yet recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 202 (estimated)
- First submitted
- 12 May 2025
- Start date
- Oct 2026
- Primary completion date
- May 2028
- Lead sponsor
- Ablative Solutions, Inc.
- Diseases
- High blood pressure
- NCT number
- NCT07083765
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 202
- From Oct 2026 to the primary completion date, May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Lab values
- 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.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tennova Turkey Creek Medical Center Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.