Continued Access Study VIG Anastomotic Connector — VIG-CAS  

Dialysis Access Malfunction Clinical Trial

Official title: Continued Access Study of the InterGraft™ Venous Anastomotic Connector for Minimally Invasive Connection of an Arteriovenous Graft for Hemodialysis

Status Completed

Clinical Trial Summary

The continued access study of the InterGraft Venous Anastomotic Connector (Venous InterGraft Continued Access Study, or 'VIG-CAS') allows for continued enrollment of subjects while the marketing application is being prepared and subsequently reviewed by FDA. The VIG-CAS will include the same patient population, follow-up schedule, and study endpoints as the VIG pivotal study.

Clinical Trial Description

The VIG-CAS is a multicenter, prospective, single-arm study that will include up to 15 subjects contributed from up to 5 study sites that previously participated in the VIG pivotal study. No new investigators will be included. All subjects will be assigned to treatment with the VIG and a standard sutured arterial anastomosis for implantation of an arteriovenous graft (AVG) for hemodialysis. The selection criteria (patient population), follow-up schedule, and study endpoints are the same as those used in the pivotal study.

Study data will be collected up to the point at which each subject has completed the final 6-month follow up or experienced a terminal study event. ;

Related Conditions & MeSH terms

• Dialysis Access Malfunction

• NCT number: NCT05448950
• Study type: Interventional
• Source: Phraxis, Inc.
• Status: Completed
• Phase: N/A
• Start date: June 7, 2022
• Completion date: March 8, 2023