Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

W.L. Gore & Associates

Status and phase: Completed; Phase 3; Phase 2

Conditions: End Stage Renal Disease

Treatments: Device: GORE® ACUSEAL Vascular Graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT01173718

AVG 08-06

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:>

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

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2. Patient is currently on hemodialysis or ready to begin hemodialysis within 30 days following placement of study device. > >>

3. The patient must be able to have the vascular access graft placed in an upper extremity. >

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4. The patient is 18 years of age or older. >

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

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6. The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements. > >>

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

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   >> Exclusion Criteria:>

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

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

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

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

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6. The patient is enrolled in another investigational study.>

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

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8. Study device is intended to be used temporarily.>

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

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10. Patient is taking Aggrenox®.>

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11. 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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12. 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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13. The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.>

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14. Life expectancy is less than 12 months.>

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15. The patient is pregnant.>

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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138 participants in 1 patient group

GORE® ACUSEAL Vascular Graft

Experimental group

Treatment:

Device: GORE® ACUSEAL Vascular Graft