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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014