The objectives of this prospective, randomized, single-blind multicenter study are to demonstrate the safety and efficacy of SELUTION SLR in the treatment of failed AV fistulae in patients undergoing renal dialysis. This study will also qualify for EU MDR approval.
Eighty-four subjects are being randomized to either SELUTION SLR or plain balloon angioplasty. To qualify for inclusion they must be aged 18–90, have a dialysis access that has performed at least one successful dialysis session, and a stenosis of more than 50% at the outflow vein.
“We are excited to study this novel sustained release of sirolimus in our dialysis patients with a malfunctioning fistula,” said Konstantinos Katsanos, consultant in Interventional Radiology at the University of Patras in Patras, Greece. “We truly look forward to the outcomes.”
The primary efficacy endpoint of the study will be primary patency of the treated lesion and of the treated circuit at six months post-intervention. The primary safety endpoint will be freedom from any serious adverse events involving the AV access circuit or the patient at 30 days.
“MedAlliance is honored to initiate this important study with Dr Katsanos,” added chairman and CEO Jeffrey B. Jump. “It will hopefully demonstrate extended life for AV Fistula patients around the world.”
SELUTION SLR’s technology involves unique Microreservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These microreservoirs provide controlled and sustained release of the drug. Extended release of sirolimus from stents has been demonstrated highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT (Cell Adherent Technology) enables the microreservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.