Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

Phase

2/3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01173718

AVG 08-06

Ages > 18
All Genders

Study 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).

> 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Patient is currently on hemodialysis or ready to begin hemodialysis within 30 daysfollowing placement of study device.

The patient must be able to have the vascular access graft placed in an upperextremity.

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 tocomply with follow-up requirements.

The patient or his/her legal guardian is willing to provide informed consent.

Exclusion

Exclusion Criteria:

The patient has a documented and unsuccessfully treated ipsilateral central venousstenosis via imaging technique.

The patient currently has a known or suspected systemic infection.

The patient has a known hypercoagulable or bleeding disorder or requires treatmentwith 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 unrelatedto 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 studyand 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 procedurewithin 30 days of the study procedure.

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

The patient has a known hypercoagulable or bleeding disorder or requires treatmentwith 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).

Study Design

July 01, 2010

February 28, 2013