Evaluation of the GORE ACUSEAL Vascular Graft for Hemodialysis Access
This study will be a prospective, non-randomized, multi-center evaluation of the performance of the GORE ACUSEAL Vascular Graft. The ACUSEAL 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the GORE ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL, AVG 08-06)|
- Cumulative Patency at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Percentage of Subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.
- Freedom from bleeding at 6 mos [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Percentage of subjects free from both major and minor bleeding events, assessed at 6-months
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||April 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
|Experimental: GORE ACUSEAL Vascular Graft||
Device: GORE ACUSEAL Vascular Graft
Surgical implantation of the GORE ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
Other Name: Vascular graft