Continued Access Study VIG Anastomotic Connector

NACompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

June 7, 2022

Primary Completion Date

March 8, 2023

Study Completion Date

March 8, 2023

Conditions
Dialysis Access Malfunction
Interventions
DEVICE

VIG Continued Access Study

Small skin incisions will be made for tunneling the graft under the skin in a standard manner. The VIG device is provided pre-loaded within a customized catheter-based delivery system for over-the-wire delivery. The VIG is inserted through an introducer sheath placed in the target vein so that the 'vessel end' of the VIG is deployed within the vein, and the 'graft end' extends out of the vein for connection to the graft. Delivery and deployment will be performed under fluoroscopic guidance. The VIG will be deployed first, connected to the AVG, then the graft and VIG will be flushed and clamped. The arterial anastomosis will then be created using a standard suturing method.

Trial Locations (2)

28226

Surgical Specialists of Charlotte, Charlotte

36301

Trinity Research Group, LLC, Dothan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Phraxis, Inc.

INDUSTRY