ACT I early feasibility study of the Voyager Ark vascular access device.

Abstract

We report the 6-month outcomes of the Ark Cannulation Trial (ACT) I early feasibility study. This investigation examined the Ark as a potential innovative access tool for overcoming cannulation-related challenges and improving arteriovenous fistula (AVF) dependent hemodialysis through targeted cannulation. During this first-in-human, interventional, prospective, single arm, single site investigation, 13 patients were treated. Cohort 1 included patients with existing fistulas meeting the criteria for Ark implantation at planned sites, including depth (4-15 mm), diameter (⩾4 mm), flow (⩾500 mL/min) and a poorly accessible cannulation zone. Cohort 2 included patients who underwent AVF creation and implantation of Arks at time of initial surgery. For both Cohorts, clinical need determined if one or two Arks were implanted. The primary endpoint was effective initial cannulation of the access site after Ark implantation. The secondary endpoint was continued access of the Ark cannulation zone for hemodialysis and evaluation of device or procedure-related adverse events collected for 6 months post-implantation. The exploratory endpoint evaluated the Ark implantation procedure. Of 13 patients, 2 were withdrawn prior to initial cannulation through the Ark-1 patient due to an exacerbated baseline condition and the other patient due to loss of follow-up. In the efficacy analysis, 11 of 13 treated patients demonstrated successful primary and secondary outcomes. Of the 11 treated patients who initiated cannulation through the Arks, 100% experienced successful primary and secondary outcomes. None of the patients experienced adverse events related to the Ark and surgeons had the necessary skills to implant Arks. The results demonstrated the Ark could be used successfully in End-Stage Renal Disease (ESRD) patients undergoing hemodialysis three times a week. These results suggest preliminary safety and efficacy of the Ark as a promising cannulation tool for dialysis vascular access and warrant further exploration of long-term safety and effectiveness through a pivotal clinical study involving a larger population and extended follow-up.