Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL)
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|ClinicalTrials.gov Identifier: NCT01173718|
Recruitment Status : Completed
First Posted : August 2, 2010
Results First Posted : July 2, 2013
Last Update Posted : July 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Device: GORE® ACUSEAL Vascular Graft||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||138 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL, AVG 08-06)|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||February 2013|
|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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173718
|Principal Investigator:||Marc Glickman, MD||Sentara Vascular Specialists|