Study Comparing VasQ External Support Implant to Standard Care for Dialysis Fistula Access in Adults with End Stage Renal Disease

What this Trial Is About

Researchers are evaluating VasQ, an external support implant designed for arteriovenous fistulas created for dialysis access in patients with end stage renal disease. This postmarket surveillance trial is prospective, multi-center, randomized, and controlled, enrolling 300 patients to compare the performance of VasQ-supported fistulas with standard care fistulas. The main question is how VasQ affects the time to achieve a clinically functional fistula compared to standard care. Participants are assigned to one of two groups those receiving an end to side fistula supported by VasQ, and those receiving a standard end to side fistula without VasQ. The primary outcome is measured at 6 months after the fistula creation procedure, with further follow-up extending to 12 months post procedure. This design allows researchers to monitor the durability and function of the fistulas over time. During the study, participants will attend follow-up visits over a 12-month period to assess fistula function and overall outcomes. Evaluations include clinical assessments of the fistulas performance to determine its functional success. The study collects data to understand the benefits and any limitations of using VasQ in arteriovenous fistula creation, supporting safety and efficacy monitoring in a real-world setting.

Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula