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TARGET BP I Clinical Trial
Sponsor: Ablative Solutions, Inc.
Summary
The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.
Official title: A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects With Hypertension
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2019-07-22
Completion Date
2026-05
Last Updated
2023-10-03
Healthy Volunteers
No
Conditions
Interventions
Dehydrated alcohol
Dehydrated Alcohol Injection, USP is used in the study.
Peregrine System Kit (Sham Procedure)
Pre-procedural diagnostic renal angiography only, performed for confirmation of anatomical eligibility prior to randomization
Locations (5)
Cardiology PC
Birmingham, Alabama, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States