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GORE Embolic Protection With Reverse Flow (EMPiRE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00594100
First received: December 20, 2007
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
Results First Received: March 19, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carotid Artery Stenosis
Intervention: Device: GORE Flow Reversal System (GFRS)

  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
The study was approved to enroll subjects from a maximum of 40 medical institutions in the United States (including public and academic research center hospitals and private practices).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
GFRS Pivotal Subjects All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).

Participant Flow for 2 periods

 Period 1:   Procedure
    GFRS Pivotal Subjects  
STARTED     245  
COMPLETED     236  
NOT COMPLETED     9  
Technical Failure                 9  

Period 2:   Follow-up Through 30 Days Post Procedure
    GFRS Pivotal Subjects  
STARTED     236  
COMPLETED     224  
NOT COMPLETED     12  
Death / Reintervention / Medical Reasons                 2  
Discontinued Prior to Visit                 6  
Missed Visit - Phone Contact Follow-up                 4  



  Baseline Characteristics
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Reporting Groups
  Description
GFRS Pivotal Subjects All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).

Baseline Measures
    GFRS Pivotal Subjects  
Number of Participants  
[units: participants]
 		  245  
Age  
[units: years]
Mean ± Standard Deviation 		  70.2  ± 9.6  
Age  
[units: years]
Median ( Full Range ) 		  71.0  
  ( 46.0 to 89.8 )  
Age, Customized  
[units: participants]
 		 
< 80 years     207  
>= 80 years     38  
Gender  
[units: participants]
 		 
Female     80  
Male     165  
History of Diabetes [1]
[units: participants]
 		 
Yes     86  
No     159  
History of Hypertension [2]
[units: participants]
 		 
Yes     212  
No     33  
History of Ischemic Stroke [3]
[units: participants]
 		 
None     192  
One     42  
Two or More     11  
Previous Endarterectomy [4]
[units: participants]
 		 
None     143  
Less than 1 Year     23  
Greater than 1 Year     79  
Symptomatic [5]
[units: participants]
 		 
Symptomatic     78  
Asymptomatic     167  
[1] Patient has a history of Diabetes prior to enrollment
[2] Patient has history of hypertension prior to study enrollment
[3] Number of prior ischemic strokes prior to enrollment
[4] Timing of previous endarterectomy (CEA)
[5] Presence of baseline neurological symptoms within 6 months prior to study enrollment



  Outcome Measures
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1.  Primary:   Composite Major Adverse Event (MAE) Rate   [ Time Frame: Treatment through 30-day visit window ]
  Show Outcome Measure 1

2.  Secondary:   Flow Reversal System Technical Success   [ Time Frame: Procedure ]
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3.  Secondary:   Flow Reversal System Success   [ Time Frame: Procedure ]
  Show Outcome Measure 3

4.  Secondary:   Stent Success   [ Time Frame: Procedure ]
  Show Outcome Measure 4

5.  Secondary:   Clinical Success   [ Time Frame: 24-48 Hours Post-Procedure ]
  Show Outcome Measure 5

6.  Secondary:   Patency at 30 Days   [ Time Frame: Treatment through 30-day visit window ]
  Show Outcome Measure 6


  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
No text entered.  


Results Point of Contact:  
Name/Title: Bryan Randall
Organization: W. L. Gore & Associates
phone: (800) 437-8181
e-mail: BRandall@WLGore.com


Publications:


Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00594100     History of Changes
Other Study ID Numbers: NPS 05-05
Study First Received: December 20, 2007
Results First Received: March 19, 2009
Last Updated: July 2, 2012
Health Authority: United States: Food and Drug Administration