Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

Phase 2

Completed

Brief 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). \> \>\>

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\>\> 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. \>

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\>\> Subjects will be selected from up to 20 Investigational Sites.

Recruitment & Eligibility

Inclusion Criteria

Patient requires the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease. >

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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. >

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The patient is 18 years of age or older. >

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The patient has a reasonable expectation of remaining on hemodialysis for 12 months. >

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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. >

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Exclusion Criteria

The patient has a documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.>

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The patient currently has a known or suspected systemic infection.>

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The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.>

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The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin. >

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The patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.>

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The patient is enrolled in another investigational study.>

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The patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.>

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Study device is intended to be used temporarily.>

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The patient has had >2 previous arteriovenous accesses in treatment arm.>

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Patient is taking Aggrenox®.>

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The patient is in need of, or is scheduled for a different vascular surgical procedure within 30 days of the study procedure.>

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The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone(>10 mg), cyclosporine, tacrolimus or cyclophosphamide.>

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The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.>

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Life expectancy is less than 12 months.>

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The patient is pregnant.>

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The patient is a poor compliance risk (i.e. history of IV or oral drug abuse).

Arm && Interventions

Group	Intervention	Description
GORE® ACUSEAL Vascular Graft	GORE® ACUSEAL Vascular Graft	-

Primary Outcome Measures

Name	Time	Method
Cumulative Patency at 6 Months	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	6 Months	Percentage of subjects free from both major and minor bleeding events, assessed at 6-months

Secondary Outcome Measures

Name	Time	Method
Primary Unassisted Patency at 6 Months	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)	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 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	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.