A Phase 2, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects with Hypertension, in the Absence of Antihypertensive Medications.
Trial objectiveTo obtain an assessment of the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in hypertensive subjects in the absence of antihypertensive medications.
StatusOpen to recruitment
CI/PIDr Manish Saxena (PI)
SponsorAblative Solutions, Inc.
FunderAblative Solutions, Inc.
Study summaryHigh blood pressure affects over 25% adults and is implicated in 62% of heart disease and 49% of coronary heart disease. Current treatment options include oral anti-hypertensive medications. However, a large proportion of patients do not achieve adequate blood pressure control. The difficulty in treating hypertension, its high prevalence and severe consequences, and the limitations of purely pharmacologic approaches, have prompted the development of other interventional approaches. This is a Phase 2, prospective, randomized, blinded, sham procedure-controlled, multicenter trial to assess the efficacy and safety of the destruction of nervous tissue around the kidney artery with alcohol using the Peregrine Kit. This will be an “off medication” study to confirm the basic hypothesis that destruction of nervous tissue around the kidney artery using the Peregrine Catheter and alcohol will lower the blood pressure in subjects with high blood pressure without medication. 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.
Sample size and duration90; approximately 3.5 years
Enquiries Dr Manish Saxena: email@example.comArmida Balawon: firstname.lastname@example.org