Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL)

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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Device: GORE® ACUSEAL Vascular Graft

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GORE® ACUSEAL Vascular Graft	Device: GORE® ACUSEAL Vascular Graft; Surgical implantation of the GORE® ACUSEAL Vascular Graft for Hemodialysis per the Investigator's standard of practice.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Marc Glickman, MD, Sentara Vascular Specialists

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 29, 2010
• First Submitted That Met QC Criteria: July 30, 2010
• First Posted (Estimate): August 2, 2010

Study Record Updates

• Last Update Posted (Estimate): July 26, 2013
• Last Update Submitted That Met QC Criteria: July 19, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Hemodialysis; Vascular Graft
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: AVG 08-06