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.
• 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.