12
Participants
Start Date
June 7, 2022
Primary Completion Date
March 8, 2023
Study Completion Date
March 8, 2023
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.
Surgical Specialists of Charlotte, Charlotte
Trinity Research Group, LLC, Dothan
Lead Sponsor
Phraxis, Inc.
INDUSTRY