Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01173718
First received: July 29, 2010
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
End Stage Renal Disease
Device: GORE® ACUSEAL Vascular Graft
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL, AVG 08-06)

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Cumulative Patency at 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.

  • Freedom From Bleeding at 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
    Percentage of subjects free from both major and minor bleeding events, assessed at 6-months


Secondary Outcome Measures:
  • Primary Unassisted Patency at 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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.

  • Time to Event Analysis (Cumulative Patency) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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.

  • Time to First Cannulation [ Time Frame: Time of access placement to first cannulation, assessed up to one week ] [ Designated as safety issue: No ]
    The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft.

  • Time to Potential Central Venous Catheter Removal [ Time Frame: Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123 ] [ Designated as safety issue: No ]
    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.


Enrollment: 138
Study Start Date: July 2010
Study Completion Date: February 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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  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.

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  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.

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

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Exclusion Criteria:

  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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173718

Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Marc Glickman, MD Sentara Vascular Specialists
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01173718     History of Changes
Other Study ID Numbers: AVG 08-06
Study First Received: July 29, 2010
Results First Received: May 8, 2013
Last Updated: July 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by W.L.Gore & Associates:
Hemodialysis
Vascular Graft

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on April 23, 2014