At a glance
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Clinical Evaluation of a Vascular Venous Anastomotic Connector for Minimally Invasive Connection of an Arteriovenous Graft for Hemodialysis [InterGraft VIG-only Study]
In Brief
A clinical study evaluating Venous InterGraft Connector, sutured arterial anastomosis of an implanted vascular graft for hemodialysis, and 1 other intervention for End Stage Renal Disease. Completed, enrolled 158 participants across 10 sites.
Detailed Summary
The InterGraft™ Venous Anastomotic Connector provides an endovascular, minimally invasive means for attachment of an arteriovenous graft to a vein in the upper extremity. The InterGraft™ Venous Anastomotic Connector facilitates creation of the arteriovenous graft connection to a vein in support of hemodialysis in subjects with End Stage Renal Disease. The InterGraft™ Venous Anastomotic Connector is used together with conventional suturing of the arterial anastomosis to facilitate creation of an arteriovenous graft in support of hemodialysis in subjects with End Stage Renal Disease.
Study Details
Timeline
Interventions
The device is designed for transcatheter delivery within a vein and connection to an AVG that has been tunneled under the skin in a standard manner. The connection is made via a small skin incision.
The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.
The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.