Evaluating the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis in Adults with End-Stage Renal Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the InnAVasc Arteriovenous Graft IG for patients with end-stage renal disease ESRD who require hemodialysis and need an arteriovenous graft for vascular access. The study aims to measure the proportion of patients maintaining secondary patency of the graft at 6 months and to monitor adverse events related to the device during this period. Participants will receive the InnAVasc Arteriovenous Graft surgically implanted in the forearm or upper arm using standard vascular surgical techniques. The graft can be placed in a straight configuration in the upper arm or in a looped configuration in the forearm or upper arm, avoiding placement across the elbow. Patients must be able to continue or start antiplatelet therapy after the implant. The study includes periodic follow-up visits and assessments for up to two years after implantation. During the study, participants will undergo assessments to monitor graft function, safety, and successful use for hemodialysis. Researchers will collect data on device patency, adverse events, and the ability to cannulate the graft within seven days of surgery. Follow-up evaluations will continue at multiple time points up to 24 months to assess sustained graft use and patient outcomes. Participants are expected to provide informed consent and attend all scheduled visits throughout the study duration.

A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease