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
Results First Received: May 8, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: End Stage Renal Disease
Intervention: Device: GORE® ACUSEAL Vascular Graft

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
GORE® ACUSEAL Vascular Graft GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.

Participant Flow:   Overall Study
    GORE® ACUSEAL Vascular Graft  
STARTED     138  
COMPLETED     94  
NOT COMPLETED     44  
Death                 17  
Abandonment of study graft                 27  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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

Baseline Measures
    GORE® ACUSEAL Vascular Graft  
Number of Participants  
[units: participants]
  138  
Age  
[units: years]
Mean ± Standard Deviation
  63  ± 13.8  
Gender  
[units: participants]
 
Female     71  
Male     67  
Region of Enrollment  
[units: participants]
 
United States     138  



  Outcome Measures
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1.  Primary:   Cumulative Patency at 6 Months   [ Time Frame: 6 Months ]

2.  Primary:   Freedom From Bleeding at 6 Months   [ Time Frame: 6 Months ]

3.  Secondary:   Primary Unassisted Patency at 6 Months   [ Time Frame: 6 Months ]

4.  Secondary:   Time to Event Analysis (Cumulative Patency)   [ Time Frame: 6 Months ]

5.  Secondary:   Time to First Cannulation   [ Time Frame: Time of access placement to first cannulation, assessed up to one week ]

6.  Secondary:   Time to Potential Central Venous Catheter Removal   [ Time Frame: Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Debby Pfile, Clinical Research Associate
Organization: W. L. Gore & Associates
phone: 623-234-5226
e-mail: dpfile@wlgore.com


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