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Evaluation of the GORE TIGRIS Vascular Stent (TIGRIS)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
W.L.Gore & Associates Identifier:
First received: March 29, 2012
Last updated: August 24, 2016
Last verified: August 2016
Results First Received: August 24, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Peripheral Arterial Disease
Interventions: Device: TIGRIS Vascular Stent
Device: BARD

  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
TIGRIS Vascular Stent TIGRIS Vascular Stent: Implant
BARD(r) LifeStent BARD: Implant

Participant Flow:   Overall Study
    TIGRIS Vascular Stent   BARD(r) LifeStent
STARTED   197   70 
COMPLETED   178   64 

  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.
Per Protocol Population

Reporting Groups
TIGRIS Vascular Stent TIGRIS Vascular Stent: Implant
BARD(r) LifeStent BARD: Implant
Total Total of all reporting groups

Baseline Measures
    TIGRIS Vascular Stent   BARD(r) LifeStent   Total
Overall Participants 
[units: participants]
 197   70   267 
[units: years]
Mean (Standard Deviation)
 66.8  (9.30)   67.9  (8.87)   67.0  (9.17) 
[units: participants]
Female   56   21   77 
Male   141   49   190 
Region of Enrollment 
[units: participants]
United States   142   54   196 
Europe   55   16   71 

  Outcome Measures
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1.  Primary:   Primary Safety Endpoint - Major Adverse Events   [ Time Frame: 30 Days ]

2.  Primary:   Primary Efficacy Endpoint - Primary Patency   [ Time Frame: 12 Months ]

3.  Secondary:   Procedural Success   [ Time Frame: Within 48 hours of initial device implant ]

4.  Secondary:   Device Success   [ Time Frame: Immediately following initial device implant (usually within a few minutes to an hour). ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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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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  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Thomas Sabin
Organization: W.L. Gore & Associates
phone: 928-864-3153

Responsible Party: W.L.Gore & Associates Identifier: NCT01576055     History of Changes
Other Study ID Numbers: PCE 09-02
Study First Received: March 29, 2012
Results First Received: August 24, 2016
Last Updated: August 24, 2016
Health Authority: United States: Food and Drug Administration