NCT01173718

Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL, AVG 08-06)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving or expected to require hemodialysis through a prosthetic vascular graft within 30 days. Gore proposes to demonstrate that the 6 month cumulative patency of the GORE® ACUSEAL Vascular Graft is similar to that of other arteriovenous grafts (AVGs). \> \>\> \> \>\> A total of 138 Subjects will be enrolled. Once the study procedure has been successfully completed, cannulation may occur at any time at the Investigator's discretion. \> \>\> \> \>\> Subjects will be selected from up to 20 Investigational Sites.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	GORE® ACUSEAL Vascular Graft	Surgical implantation of the GORE® ACUSEAL Vascular Graft for Hemodialysis per the Investigator's standard of practice.

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-09-01
• Completion: 2013-02-01
• First posted: 2010-08-02
• Last updated: 2013-07-26
• Results posted: 2013-07-02