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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

July 29, 2010
July 19, 2013
July 2010
September 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01173718 on ClinicalTrials.gov Archive Site
  • 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.
Freedom from bleeding at 6 mos [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Percentage of subjects free from both major and minor bleeding events, assessed at 6-months
Not Provided
Not Provided
 
Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access
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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
End Stage Renal Disease
Device: GORE® ACUSEAL Vascular Graft
Surgical implantation of the GORE® ACUSEAL Vascular Graft for Hemodialysis per the Investigator's standard of practice.
Experimental: GORE® ACUSEAL Vascular Graft
Intervention: Device: GORE® ACUSEAL Vascular Graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
February 2013
September 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01173718
AVG 08-06
Yes
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Principal Investigator: Marc Glickman, MD Sentara Vascular Specialists
W.L.Gore & Associates
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP