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The William Harvey Research Institute - Barts and The London

The TARGET BP I Trial

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

Trial objective
To evaluate the efficacy of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in uncontrolled hypertensive subjects when used in combination with antihypertensive medications.

Disease area
Hypertension

Status
Open to recruitment

CI/PI
Dr Manish Saxena (PI)

Sponsor
Ablative Solutions, Inc.

Study summary
This is a Phase 3, multicenter, blinded, sham procedure-controlled trial of renal denervation by the Peregrine System Kit in subjects with Hypertension. The main purpose of the trial is to assess the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine system kit in uncontrolled hypertensive subjects when used in combination with antihypertensive medications. The investigational product is a co-packaged combination product, the Peregrine System™ Kit. This contains a device component, the Peregrine System™ Infusion Catheter, and a drug component, Dehydrated Alcohol Injection, USP.

Enquiries
Dr Manish Saxena: m.saxena@qmul.ac.uk
Armida Balawon: a.balawon@qmul.ac.uk