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The TARGET BP OFF-MED Trial

NCT03503773 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2025-05-14

Study results available
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Summary

To 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.

Conditions

Interventions

DRUG

Alcohol

Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries

OTHER

Sham control

endovascular, renal angiography

Sponsors & Collaborators

  • Ablative Solutions, Inc.

    lead INDUSTRY

Principal Investigators

  • Felix Mahfoud, Prof.Dr.med. · Universitätsklinikum des Saarlandes Klinik für Innere Medizin III Kardiologie, Angiologie und Internistische Intensivmedizin, Germany

  • Atul Pathak, Prof. · Clinique Pasteur Hi-LAB, Toulouse, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2022-01-31
Completion
2024-01-10

Countries

  • Belgium
  • France
  • Germany
  • United Kingdom

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 NCT03503773 on ClinicalTrials.gov