The TARGET BP Clinical Program
The Peregrine System Kit is being evaluated for the treatment of hypertension in two ongoing clinical trials as part of the TARGET BP Clinical Program. Together, the Peregrine System Infusion Catheter and Ablative Solutions dehydrated alcohol make up the Peregrine Kit which is used during the Peregrine Procedure.
TARGET BP OFF-MED Clinical Trial
The TARGET BP OFF-MED Clinical Trial is evaluating the Peregrine Kit. Early studies1-3 of the Peregrine Catheter using a neurolytic agent 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 effectiveness of the Peregrine Kit in treating high 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.
TARGET BP I Clinical Trial
Under a Clinical Trial Application (CTA), Ablative Solutions is studying the Peregrine Kit for transcatheter alcohol-medicated renal denervation for the treatment of uncontrolled hypertension with targeted delivery of alcohol, an investigational medicinal product. 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, in conjunction with antihypertensive medical therapy. Enrollment in the company’s randomized global TARGET BP I multi-center trial will begin in U.S. and European centers in 2019.
Data from the TARGET BP I trial will be used to seek approval in the European Union and the United States for the system's use for the treatment of hypertension.
1Mahfoud 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
2Persu 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
3Fischell, Ebner et al, Transcatheter Alcohol-Mediated Perivascular Renal Denervation with the Peregrine System, JACC: Cardiovasc Interv. 2016 Mar 28;9(6):589-98