At a glance
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Continued Access Study of the InterGraft™ Venous Anastomotic Connector for Minimally Invasive Connection of an Arteriovenous Graft for Hemodialysis
In Brief
A clinical study evaluating VIG Continued Access Study for Dialysis Access Malfunction. Completed, enrolled 12 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.