MedAlliance has announced completion of patient enrolment in the ISABELLA clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of dysfunctional arteriovenous (AV) fistulas in end-stage renal failure patients undergoing haemodialysis.
Selution SLR (sustained limus release) is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to a drug-eluting stent (DES).
ISABELLA (Intervention with Selution SLR agent balloon for endovascular latent limus therapy for failing AV fistulas) is a prospective, single-centre, multi-investigator, non-blinded, single-arm trial investigating the safety and feasibility of the Selution SLR 018 DEB for the treatment of failing AV fistulas in 40 haemodialysis patients.
The objective of this study is to determine the safety and efficacy of the Selution SLR 018 DEB in the treatment of dysfunctional AV fistulas in end-stage renal failure patients undergoing haemodialysis. The anticipated clinical benefit is to improve the target lesion primary patency and reduce the number of reinterventions in stenotic AV fistulas of haemodialysis patients and hence morbidity in this frail patient population compared to conventional balloon angioplasty.
The efficacy endpoint of interest is six-month target lesion primary patency and the safety endpoint is freedom from localised or systemic serious adverse events through 30 days that reasonably suggest the involvement of the AV fistula circuit. The study has recently completed its 40-patient recruitment and will follow them up for a period of two years at Singapore General Hospital (SGH), which performs over 3,000 access salvage procedures annually.
“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 (SEB) angioplasty using the Selution SLR DEB catheter combined with high pressure conventional balloon angioplasty vessel preparation, for dysfunctional AVF circuits in Asian haemodialysis patients”, said lead principal investigator associate professor Tjun Tang, senior consultant vascular and endovascular surgeon at SGH.
“SEBs 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 post-angioplasty, which is a major advantage over other drug-coated balloons in dealing with the extended nature of the NIH [National Institutes of Health] process. Our plan is to follow up patients to two years to define the effectiveness of the studied therapy in the medium term.”