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Renal denervation (RDN) remains a promising approach for the treatment of hypertension and other disorders. Preclinical and early clinical studies have demonstrated the safety of the Peregrine System™ Infusion Catheter to infuse a neurolytic agent (i.e. alcohol) to the perivascular space to perform RDN.
The Peregrine Post-Market Study is a prospective, single arm, open label trial, conducted at up to 20 sites in Europe. Up to 120 subjects with hypertension will undergo RDN using a neurolytic agent. The primary 1-month safety endpoints include: major vascular complications, major bleeding, renal injury, and death. The primary efficacy endpoint is the reduction of the 24-hour mean systolic ABPM at 6-months vs. baseline. Dehydrated Alcohol (0.6 mL/artery) has been chosen as the neurolytic agent based upon safety, efficacy and dose-responses observed in preclinical and clinical studies. Preclinical studies have demonstrated 0.6 mL/artery to be safe, and with a signal of increased efficacy compared to a 0.3 mL/ artery dose. One-month data from the first 5 subjects will be assessed by the DSMB before proceeding with additional subjects. Major inclusion criteria include age (18-85), OBP (≥ 150 mmHg), ABPM (≥ 135 mm Hg), in patients taking ≥ 3 anti-hypertensive medications, including a diuretic. Medication compliance is monitored for 28 days and baseline ABPM is obtained within 14 days prior to the procedure. Once deemed eligible, subjects will undergo RDN with alcohol using the Peregrine Catheter. Post-treatment assessments include laboratory assessment, renal artery imaging, ABPM and OBP. Medication compliance post-treatment will be monitored by urine analysis. Subjects will be followed for 12-months.
This protocol has been approved by local ethics committees and the first patients have been enrolled at 2 study sites. Early experience data will be presented.
Chemical RDN using 0.3 mL alcohol/renal artery of alcohol has been shown to be feasible, safe, and effective in reducing blood pressure. The dose of 0.6 mL is now being evaluated for safety and performance in this post-market study. Preliminary results will be presented.