Intervention with selution SLR™ Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas (ISABELLA) Trial: Protocol for a pilot clinical study and pre-clinical results.
Tjun Yip TangTze-Tec ChongCharyl Jia Qi YapShereen Xue Yun SoonSze Ling ChanRu Yu TanHao Yun YapHsien Ts'ung Luke TayChieh-Suai TanScott BarnhillDavid HellingaR Tyler DeGrawAloke V FinnPublished in: The journal of vascular access (2021)
Long release sirolimus coated balloons may serve as a promising novel alternative therapy to paclitaxel-based technology for treating conduit stenosis secondary to neointimal hyperplasia. Pre-clinical pharmacokinetic and histological animal data are encouraging and provide suggestion of safety and efficacy in this setting. This single-center trial will provide a first step toward demonstration of efficacy and safety of this device for treatment of stenotic fistulas.