Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting (WISE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gardia Medical
ClinicalTrials.gov Identifier:
NCT01783639
First received: January 13, 2013
Last updated: July 26, 2015
Last verified: June 2015
Results First Received: June 8, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Carotid Artery Diseases
Stroke
Intervention: Procedure: Carotid Artery 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
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
WIRION

Device: WIRION™ Embolic Protection System

Interventions: Carotid Artery Stent

Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices


Participant Flow:   Overall Study
    WIRION  
STARTED     142  
COMPLETED     120  
NOT COMPLETED     22  
Did not meet inclusion/exclusion                 21  
Clinical indication for proximal EPD                 1  



  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
Arm 1

Device: WIRION™ Embolic Protection System

Interventions: Carotid Artery Stent

Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices


Baseline Measures
    Arm 1  
Number of Participants  
[units: participants]
  120  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     13  
>=65 years     107  
Age  
[units: years]
Mean (Standard Deviation)
  74.9  (8.0)  
Gender  
[units: participants]
 
Female     33  
Male     87  
Region of Enrollment  
[units: participants]
 
Belgium     11  
Italy     40  
Germany     69  



  Outcome Measures

1.  Primary:   The Rate of Peri-procedural (Within 30 Days of Procedure) Death, Stroke, and Myocardial Infarction.   [ Time Frame: Within 30 Days of procedure ]

2.  Secondary:   The Rate of Device Success   [ Time Frame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   The Rate of Clinical Success   [ Time Frame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   The Rate of Access Site Complications   [ Time Frame: Within 30 Days of procedure ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Neurological Events Occurring Within 30 Days Post Procedure,Including Strokes and Transient Ischemic Attacks   [ Time Frame: Within 30 Days of procedure ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Angiographic Success   [ Time Frame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   Procedural Success   [ Time Frame: Participants will be followed for the duration of the procedure, an expected average of 35 minutes ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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: Dr. Vardit Segal
Organization: Gardia Medical
phone: +972-4-6277166 ext 106
e-mail: Vardit@Gardiamedical.com


No publications provided


Responsible Party: Gardia Medical
ClinicalTrials.gov Identifier: NCT01783639     History of Changes
Other Study ID Numbers: WIRION™ Pivotal Study (WISE), WIRION Study Europe (WISE)
Study First Received: January 13, 2013
Results First Received: June 8, 2015
Last Updated: July 26, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices