Clinical trial NCT01173718: Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access
Official title: Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL, AVG 08-06)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: End Stage Renal Disease
Keywords: Hemodialysis
Vascular Graft
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2010-08-02
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Cumulative Patency at 6 Months
timeFrame: 6 Months
measure: Freedom From Bleeding at 6 Months
timeFrame: 6 Months
Secondary outcomes:
measure: Primary Unassisted Patency at 6 Months
timeFrame: 6 Months
measure: Time to Event Analysis (Cumulative Patency)
timeFrame: 6 Months
measure: Time to First Cannulation
timeFrame: Time of access placement to first cannulation, assessed up to one week
measure: Time to Potential Central Venous Catheter Removal
timeFrame: Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123
Other outcomes:
Locations:
Study officials:
affiliation: Sentara Vascular Specialists
name: Marc Glickman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Glickman MH, Burgess J, Cull D, Roy-Chaudhury P, Schanzer H. Prospective multicenter study with a 1-year analysis of a new vascular graft used for early cannulation in patients undergoing hemodialysis. J Vasc Surg. 2015 Aug;62(2):434-41. doi: 10.1016/j.jvs.2015.03.020. Epub 2015 May 4.