Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAblative Solutions, Inc.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Dehydrated Alcohol Injection, USP
- Sham procedure
Treatment groups
202 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov