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-mediated 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 or 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 this 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 while not taking anti-hypertensive medications. Participants included patients who did not take antihypertensive medication and those on 1-2 antihypertensive medications who stopped 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. The randomized, sham-controlled phase of the trial was followed by a crossover phase, where patients who were randomized to the sham control arm had the opportunity to receive active treatment. The randomized controlled phase is complete, and results have demonstrated that alcohol-mediated renal denervation was safe and modest blood pressure lowering has been achieved in the treatment arm at 2 months. Antihypertensive medication burden was lower in the renal denervation group through 12 months. The reduced medication burden observed in the renal denervation group, relative to the sham control group, may be due to better blood pressure control associated with renal denervation and a reduced need for medications. This observation suggests a renal denervation treatment effect and potential benefit for the patient up to 12 months post-procedure4. Subjects who entered the crossover arm are in the final follow-up phase of the study.
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 et al, Transcatheter Alcohol-Mediated Perivascular Renal Denervation with the Peregrine System, JACC: Cardiovasc Interv. 2016 Mar 28;9(6):589-98
4Pathak et al. Alcohol-Mediated Renal Denervation in Patients with Hypertension in the Absence of Antihypertensive Medications. EuroIntervention. 2023;19(7):602-611.