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Completed

NCT Number: NCT01173718

Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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  • 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:>

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  • 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).

Treatment and study plan

GORE® ACUSEAL Vascular Graft

Device

Surgical implantation of the GORE® ACUSEAL Vascular Graft for Hemodialysis per the Investigator's standard of practice.

Primary outcomes

  1. Cumulative Patency at 6 Months

    Time frame: 6 Months

    Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.

  2. Freedom From Bleeding at 6 Months

    Time frame: 6 Months

    Percentage of subjects free from both major and minor bleeding events, assessed at 6-months

Secondary outcomes

  1. Primary Unassisted Patency at 6 Months

    Time frame: 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.

  2. Time to Event Analysis (Cumulative Patency)

    Time frame: 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.

  3. Time to First Cannulation

    Time frame: 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.

  4. Time to Potential Central Venous Catheter Removal

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

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

Acronym: ACUSEAL

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Aug 2, 2010
Registry last updated
Jul 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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