Our Clinical Research
ACT II IDE Trial
Currently Enrolling
Objective: Evaluate the safety and efficacy of the VenaSure Vascular Access Device for patients undergoing hemodialysis procedures.
Design:
- Prospective, single-arm, open-label multicenter IDE trial
- Conducted at up to 15 U.S. sites
- Up to 100 patients
Primary Efficacy Endpoint:
- Incidence of success for achieving clinically functional access within a 6-month timeframe from approved cannulation through the study device.
Primary Safety Endpoint:
- The assessment and occurrence of device-related, serious adverse events (SAEs) of clinical interest (infection, aneurysm, complicated seroma) during a 12- month follow-up period from initial implantation.
ACT I Early Feasibility Trial
The results demonstrated that VenaSure 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 VenaSure as a promising cannulation tool for dialysis vascular access.