Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

Study Overview
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Brief Summary
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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.

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

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Device: GORE® ACUSEAL Vascular Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:> Patient requires the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease. > >> Patient is currently on hemodialysis or ready to begin hemodialysis within 30 days following placement of study device. > >> The patient must be able to have the vascular access graft placed in an upper extremity. > >> The patient is 18 years of age or older. > >> The patient has a reasonable expectation of remaining on hemodialysis for 12 months. > >> The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements. > >> The patient or his/her legal guardian is willing to provide informed consent. > >> > >> > >> Exclusion Criteria:> >> The patient has a documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.> >> The patient currently has a known or suspected systemic infection.> >> The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.> >> The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin. > >> The patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.> >> The patient is enrolled in another investigational study.> >> The patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.> >> Study device is intended to be used temporarily.> >> The patient has had >2 previous arteriovenous accesses in treatment arm.> >> Patient is taking Aggrenox®.> >> The patient is in need of, or is scheduled for a different vascular surgical procedure within 30 days of the study procedure.> >> The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone(>10 mg), cyclosporine, tacrolimus or cyclophosphamide.> >> The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.> >> Life expectancy is less than 12 months.> >> The patient is pregnant.> >> The patient is a poor compliance risk (i.e. history of IV or oral drug abuse).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GORE® ACUSEAL Vascular Graft<br> | Device: GORE® ACUSEAL Vascular Graft<br>* Surgical implantation of the GORE® ACUSEAL Vascular Graft for Hemodialysis per the Investigator's standard of practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Patency at 6 Months | Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month. | 6 Months | 
| Freedom From Bleeding at 6 Months | Percentage of subjects free from both major and minor bleeding events, assessed at 6-months | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Unassisted Patency at 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. | 6 Months | 
| Time to Event Analysis (Cumulative Patency) | 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. | 6 Months | 
| Time to First Cannulation | The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft. | Time of access placement to first cannulation, assessed up to one week | 
| Time to Potential Central Venous Catheter Removal | 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. | Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Vascular Graft