A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension.
Trial objectiveTo evaluate the efficacy of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in uncontrolled hypertensive subjects when used in combination with antihypertensive medications.
StatusOpen to recruitment
CI/PIDr Manish Saxena (PI)
SponsorAblative Solutions, Inc.
Study summaryThis is a Phase 3, multicenter, blinded, sham procedure-controlled trial of renal denervation by the Peregrine System Kit in subjects with Hypertension. The main purpose of the trial is to assess the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine system kit in uncontrolled hypertensive subjects when used in combination with antihypertensive medications. The investigational product is a co-packaged combination product, the Peregrine System™ Kit. This contains a device component, the Peregrine System™ Infusion Catheter, and a drug component, Dehydrated Alcohol Injection, USP.
EnquiriesDr Manish Saxena: email@example.comArmida Balawon: firstname.lastname@example.org