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ACTIVE NOT RECRUITING
NCT02910414
PHASE3

TARGET BP I Clinical Trial

Sponsor: Ablative Solutions, Inc.

View on ClinicalTrials.gov

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

DRUG

Dehydrated alcohol

Dehydrated Alcohol Injection, USP is used in the study.

DEVICE

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