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TARGET BP I Clinical Trial

NCT02910414 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-10-03

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Ablative Solutions, Inc.

    lead INDUSTRY

Principal Investigators

  • David Kandzari, MD · Piedmont Heart Institute

  • Michael Weber, MD · SUNY Downstate Medical

  • Atul Pathak, MD · Clinique Pasteur

  • Felix Mahfoud, MD · Klinik fur Innere Medizin III

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-22
Primary Completion
2023-12-31
Completion
2026-05-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02910414 on ClinicalTrials.gov