Abstract
PURPOSE: Dysfunctional vascular access due to stenosis/occlusion within the arteriovenous fistula or graft (AVF/AVG) negatively affects the clinical management of patients undergoing hemodialysis. Results from the feasibility study of the WRAPSODY™ Cell-Impermeable Endoprosthesis demonstrated that the device can achieve high patency rates and maintain integrity of the dialysis outflow circuit. This study was designed to assess real-world evidence of safety and efficacy outcomes following device placement. MATERIALS AND METHODS: This is a prospective, multicenter, non-investigational, post-market observational study of 500 patients at up to 50 centers worldwide with a mature AVF/AVG dialysis access (≥ 1 hemodialysis session) who experience stenosis/occlusion of the outflow circuit prior to placement of WRAPSODY. Patients will be divided into the following two cohorts: peripheral or central thoracic. Primary outcome measures include target lesion primary patency (TLPP) at 6 months and procedure and/or device-related events through 30 days post-procedure. Secondary outcome measures include TLPP, safety events, and the number of interventions needed to maintain patency through the 24 month study period. Exploratory endpoints include time to access abandonment, resumption of successful dialysis, functional patency, and pending available imaging data, any incidence of stent fractures, migration, or edge stenosis. Study enrollment began in June 2022, the last patient visit is expected in 2026. DISCUSSION: It is expected that this study will provide real-world evidence regarding the performance of the WRAPSODY device in a diverse population of patients, which may encourage its use in the continuum of hemodialysis access management. TRIAL REGISTRATION: NCT05062291.