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Alcohol-mediated endovascular renal denervation (RDN) using the Peregrine System™ has been shown to be safe, with a good indication of effectiveness as measured by office blood pressure (OBP). A safety and performance trial is on-going; we report preliminary data from the first 10 subjects.
The Peregrine Study is a prospective, multicenter study to treat up to 60 patients with refractory hypertension who are on a stable regimen of ≥ 3 antihypertensive drugs, including a diuretic. Patients are pre-screened for medication adherence and an OBP of ≥ 160 mm Hg. Enrolled subjects undergo both a physical exam and consult by a hypertensionist. For 28 days pre-procedure, subjects maintain journals of medications and home-measured BP. The daytime mean ABPM must be ≥ 135 mm Hg and renal artery anatomy is assessed by CTA. Other inclusion/exclusion criteria are typical for RDN studies. Endovascular chemical RDN is performed, usually without the need for sedation. The neurolytic agent is infused through the Peregrine catheter into the perivascular space of each renal artery. Alcohol at 0.3 mL/renal artery was chosen as the neurolytic agent. The primary safety endpoints include: major vascular complications, major hemorrhage, CVA, MI, and sudden death at the time of the procedure. The primary performance endpoint is the reduction in systolic OBP of 10% at 6-month compared to baseline.
For these 10 subjects the primary safety endpoint has been met: All procedures have been completed successfully. There have been no device complications. Preliminary analysis shows a mean procedure time of 7±4 minutes and fluoroscopy time of 12±7 min. CTA evaluation of renal arteries at 1-month post procedure, and data from the performance endpoint will be presented. BP data from the interim time-points show a mean reduction in systolic OBP (mm Hg): at 1-month of 17.2% (-29±13), at 3-month of 21.7% (-37± 14). Mean 24-hour systolic ABPM (mm Hg) has been reduced as well: at 1-month -12±6, at 3-month -7±10.
Preliminary analysis of the first 10 subjects in the Peregrine study show the acute safety endpoint has been met and that OBP has been reduced by more than 10% in 9 of 10 subjects.