ISABELLA Evaluates MedAlliance's Selution SLR for Treatment of Failing AV Fistulas in Hemodialysis Patients

November 24, 2020—MedAlliance announced completion of patient enrollment in the ISABELLA clinical trial at Singapore General Hospital (SGH). The trial is evaluating the company's Selution SLR (sustained limus release) 018 drug-eluting balloon (DEB) for the treatment of dysfunctional arteriovenous (AV) fistulas in end-stage renal failure patients undergoing hemodialysis.

ISABELLA is a prospective single-center, multi-investigator, nonblinded, single-arm trial investigating the safety and feasibility of Selution SLR 018 DEB for the treatment of failing AV fistulas in 40 hemodialysis patients. 

The efficacy endpoint is 6-month target lesion primary patency, and the safety endpoint is freedom from localized or systemic serious adverse events through 30 days that reasonably suggest the involvement of the AV fistula circuit.

The company advised that patient follow-up will be conducted for 2 years at SGH, which performs more than 3,000 access salvage procedures annually. The ISABELLA trial's lead principal investigator is Associate Professor Tjun Tang, MD, Senior Consultant Vascular and Endovascular Surgeon at SGH.

"We are very excited at SGH and eagerly await the results from ISABELLA, which will be the first study to report clinical safety and efficacy data of sirolimus-eluting balloon angioplasty using the Selution SLR DEB catheter combined with high-pressure [conventional balloon angioplasty] vessel preparation for dysfunctional AV fistula circuits in Asian hemodialysis patients," commented Prof. Tang in the company's announcement. "Sirolimus-eluting balloons are a natural evolution of the current gold-standard treatment option of [conventional balloon angioplasty] for salvaging failing and stenotic AV fistula circuits. Paclitaxel drug-coated balloons have been used with limited success, and the data are far from conclusive. The Selution SLR DEB provides therapeutic concentrations of drug within the vessel wall for at least 90 days postangioplasty, which is a major advantage over other drug-coated balloons in dealing with the extended nature of the [neointimal hyperplasia] process. Our plan is to follow-up patients to 2 years to define the effectiveness of the studied therapy in the medium term."