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Starting soon Phase 3

Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)

NCT07083765 · tracked via the Priya Life Science Turkey tracker
Sponsor
Ablative Solutions, Inc
Phase
Phase 3
Started
2026-10
Last updated
2026-08-20

Condition(s) studied

HypertensionHypertension,Essential

Investigational drug(s) / intervention(s)

Dehydrated Alcohol Injection, USP →Sham procedure

Dehydrated Alcohol Injection, USP: Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries

Sham procedure: Endovascular, renal angiography

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Documented history of uncontrolled hypertension and is currently taking 0, 1, or 2 antihypertensive medications. 3. Is willing to discontinue any current antihypertensive medications for at least 13 weeks (5-week pre-procedure and 8-week post-procedure). 4. Has a mean 24-hour ambulatory SBP of ≥140 mmHg and ≤170 mmHg with required valid readings. Exclusion Criteria: 1. Has renal artery anatomy abnormalities. 2. Has previously undergone renal denervation. 3. 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. 4. Has documented untreated sleep apnea. 5. 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). 6. Is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only). 7. 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. 8. Has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.

Primary outcome measure(s)

  • Changes in Systolic Ambulatory Blood Pressure at 8 weeks — Baseline to 8 weeks post-treatment
    Change from baseline in mean 24-hour ambulatory systolic blood pressure

Trial sites (1)

FacilityCityRegionStatus
Tennova Turkey Creek Medical Center Knoxville Tennessee
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07083765 on ClinicalTrials.gov ↗ ← All trials in Turkey