NCT02910414

TARGET BP I Clinical Trial

A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects With Hypertension

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Ablative Solutions, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The TARGET BP I clinical trial uses a percutaneous catheter to deliver very small amounts of alcohol (neurolytic agent). The patient population for this trial is comparable to those used in other renal denervation studies, but also incorporates lessons learned from recent trials of renal denervation. This is to enable the study of an optimized patient population who stands to benefit from the intervention, in a manner that reduces possible study bias. This trial is intended to evaluate the safety and efficacy of the Peregrine Catheter when used to deliver a 0.6 mL volume of alcohol to the perivascular area of the respective renal arteries while patients are adequately managed with oral antihypertensive medications.

Conditions

• Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-07-22
• Primary completion: 2023-12-01
• Completion: 2026-05-01
• First posted: 2016-09-22
• Last updated: 2023-10-03

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study