The TARGET BP I Clinical Trial
Together, the Peregrine System Infusion Catheter and Ablative Solutions dehydrated alcohol make up the investigational Peregrine System Kit which is used during the procedure.
Under an Investigational New Drug (IND) application, Ablative Solutions is studying the investigational Peregrine System Kit for transcatheter alcohol-medicated renal denervation for the treatment of uncontrolled hypertension with targeted delivery of alcohol.
The global TARGET BP I trial is a multi-center, blinded, randomized, sham-controlled trial to evaluate the safety and efficacy of ASI’s drug-device combination therapy for the treatment of uncontrolled hypertension despite pharmacologic treatment. Enrollment in the company’s randomized global TARGET BP I multi-center trial began in U.S. and European centers in 2019. Enrollment was completed in April of 2023.
Data from the TARGET BP I trial will be used to seek approval in the United States and abroad for the product's use for the treatment of hypertension, in conjunction with medical therapy.
The TARGET BP OFF-MED Clinical Trial is also evaluating the Peregrine System Kit in patients who are either not taking anti-hypertension medications for elevated blood pressure for patients whose anti-hypertension medications have been removed. Early studies1-3 of the Peregrine Catheter using a neurolytic agent (alcohol) suggested the procedure can reduce blood pressure by deactivating specific nerves surrounding the renal (kidney) arteries that, through over-signaling, can contribute to high blood pressure.
The purpose of the trial is to investigate the safety and preliminary efficacy of the alcohol drug product when used for transcatheter alcohol-mediated renal denervation to treat patients with uncontrolled blood pressure. Participants will include patients who do not take antihypertensive medication and those on 1-2 antihypertensive medications who will stop taking these medications for 3 months during the trial, in order to clearly evaluate the benefit of the procedure alone in managing high blood pressure. Enrollment has completed for this trial, which is currently in follow up phase.
1 Mahfoud et al, TCT-562 Chemical Renal Denervation with Alcohol – The Post-Market Study Data and the Target BP Program, JACC: Sept 2018 Sept – Vol 72 – Issue 13 Suppl – p. B225
2 Persu et al, Chemical Renal Denervation with Alcohol – Long Term Results From the Peregrine Post-Market Study, Journal of Hypertension: June 2018 – Vol 36- Issue – p. e123
3 Fischell, Ebner et al, Transcatheter Alcohol-Mediated Perivascular Renal Denervation with the Peregrine System, JACC: Cardiovasc Interv. 2016 Mar 28;9(6):589-98