Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL)
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.
|End Stage Renal Disease||Device: GORE® ACUSEAL Vascular Graft||Phase 2 Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (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 ]Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.
- Freedom From Bleeding at 6 Months [ Time Frame: 6 Months ]Percentage of subjects free from both major and minor bleeding events, assessed at 6-months
- Primary Unassisted Patency at 6 Months [ Time Frame: 6 Months ]The primary unassisted patency is defined as the percentage of subjects free from the first occurence of either access thrombosis or an access procedure performed to maintain access patency.
- Time to Event Analysis (Cumulative Patency) [ Time Frame: 6 Months ]The cumulative patency at 6 months and time-to-loss of cumulative patency will be estimated using the Kaplan-Meier survival curve for time-to-event analysis to obtain estimates accounting for censoring.
- Time to First Cannulation [ Time Frame: Time of access placement to first cannulation, assessed up to one week ]The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft.
- Time to Potential Central Venous Catheter Removal [ Time Frame: Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123 ]The time to potential central venous catheter removal is defined as the time from the initial study procedure to the third consecutive cannulation through the GORE® ACUSEAL Vascular Graft in which hemodialysis is carried out. The third consecutive cannulation is a surrogate endpoint for time to CVC removal. Typically, CVC removal is ordered after the third consecutive cannulation.
|Study Start Date:||July 2010|
|Study Completion Date:||February 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 Vascular Graft for Hemodialysis per the Investigator's standard of practice.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173718
|Principal Investigator:||Marc Glickman, MD||Sentara Vascular Specialists|