Clinical Evaluation of a Vascular Venous Anastomotic Connector [InterGraft VIG-only Study]

NACompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

February 21, 2018

Primary Completion Date

January 19, 2022

Study Completion Date

January 19, 2022

Conditions
End Stage Renal Disease
Interventions
DEVICE

Venous InterGraft Connector

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.

PROCEDURE

sutured arterial anastomosis of an implanted vascular graft for hemodialysis

The arterial anastomosis of the implanted vascular graft for hemodialysis is formed using standard suturing technique.

PROCEDURE

hemodialysis

The implanted vascular graft is intended as a vascular access for performing hemodialysis treatments.

Trial Locations (10)

28207

Surgical Specialists of Charlotte, Charlotte

29303

Spartanburg Regional Medical Center, Spartanburg

29425

Medical University of South Carolina, Charleston

29506

McLeod Physician Associates II, Florence

30120

Cartersville Medical Center, LLC, Cartersville

31201

Medical Center of Central Georgia - Navicent Health, Macon

36305

Triad of Alabama/Flowers Hospital, Dothan

48202

Henry Ford Health System- Dept of Surgery, Detroit

63103

Saint Louis University, St Louis

29118-1498

Regional Medical Center of Orangeburg and Calhoun Counties, Orangeburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Phraxis, Inc.

INDUSTRY

NCT02532621 - Clinical Evaluation of a Vascular Venous Anastomotic Connector [InterGraft VIG-only Study] | Biotech Hunter | Biotech Hunter