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GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00228384
First received: September 26, 2005
Last updated: May 25, 2012
Last verified: May 2012
History of Changes
Results First Received: January 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Peripheral Vascular Diseases
Interventions: Device: GORE VIABAHN Endoprosthesis
Device: Bare Nitinol Stent

  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
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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 VIABAHN Endoprosthesis Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Bare Nitinol Stent Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.

Participant Flow:   Overall Study
    GORE VIABAHN Endoprosthesis     Bare Nitinol Stent  
STARTED     72     76  
Baseline     72     76  
30-Day Follow-up (Safety Outcome)     69     72  
Three Year Follow-up (Final)     43     47  
COMPLETED     43     47  
NOT COMPLETED     29     29  
Death                 9                 3  
Lost to Follow-up                 6                 10  
Surgical Intervention (bypass)                 5                 5  
Withdrawal by Subject                 9                 10  
Physician Decision                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
GORE VIABAHN Endoprosthesis Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
Bare Nitinol Stent Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
Total Total of all reporting groups

Baseline Measures
    GORE VIABAHN Endoprosthesis     Bare Nitinol Stent     Total  
Number of Participants  
[units: participants]
 		  72     76     148  
Age  
[units: years]
Median ( Full Range ) 		  69  
  ( 45 to 90 )   		  63  
  ( 43 to 89 )   		  67  
  ( 43 to 90 )  
Gender  
[units: participants]
 		     
Female     27     27     54  
Male     45     49     94  
Region of Enrollment  
[units: participants]
 		     
United States     72     76     148  



  Outcome Measures
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1.  Primary:   Efficacy: Primary Patency at Three Years   [ Time Frame: 3 years ]
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2.  Primary:   Safety: Composite of Major Procedural (30-day) Adverse Events (AEs)   [ Time Frame: 30 days ]
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3.  Secondary:   Primary Assisted Patency   [ Time Frame: 3 years ]
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4.  Secondary:   Secondary Patency   [ Time Frame: 3 years ]
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5.  Secondary:   Technical Success at Initial Procedure   [ Time Frame: Time of implant procedure ]
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6.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 3 years ]
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7.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 3 years ]
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8.  Secondary:   Improvement in Rutherford Classification (Clinical Success)   [ Time Frame: 3 years ]
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9.  Secondary:   Quality of Life Subject Self-assessments (Intermittent Claudication Questionnaire: ICQ) (Clinical Success)   [ Time Frame: 3 years ]
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10.  Secondary:   Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Mental Summary Score)) (Clinical Success)   [ Time Frame: 3 years ]
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11.  Secondary:   Quality of Life Subject Self-assessments (Short Form:36 (SF:36) - Physical Summary Score)) (Clinical Success)   [ Time Frame: 3 years ]
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12.  Secondary:   Change in Ankle-Brachial Index (ABI)   [ Time Frame: 3 years ]
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13.  Secondary:   Alternate Peak Systolic Velocity Ratio (PSVR) (Equal or Less Than 2.5)   [ Time Frame: 3 years ]
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14.  Secondary:   Alternate Peak Systolic Velocity Ratio (Less Than or Equal to 3.0)   [ Time Frame: 3 years ]
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15.  Secondary:   Occurrence of Stent Fracture   [ Time Frame: 1 year ]
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16.  Secondary:   Occurrence of Stent Fracture   [ Time Frame: 2 years ]
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17.  Secondary:   Occurrence of Stent Fracture   [ Time Frame: 3 years ]
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  Serious Adverse Events
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  Other Adverse Events
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  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: Chad Badorek
Organization: W. L. Gore & Associates, Inc.
phone: 800/437-8181
e-mail: cbadorek@wlgore.com


No publications provided


Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00228384     History of Changes
Other Study ID Numbers: SFA 05-03
Study First Received: September 26, 2005
Results First Received: January 27, 2012
Last Updated: May 25, 2012
Health Authority: United States: Institutional Review Board