Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke (TREVO2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT01270867
First received: January 4, 2011
Last updated: January 9, 2014
Last verified: December 2013
Results First Received: November 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ischemic Stroke
Intervention: Device: Mechanical Embolectomy

  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
Merci Retriever Patients who were randomized to the Merci Retriever
Trevo Stentriever Patients who were randomized to the Trevo Stentriever

Participant Flow:   Overall Study
    Merci Retriever     Trevo Stentriever  
STARTED     90     88  
COMPLETED     89     88  
NOT COMPLETED     1     0  



  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.
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Reporting Groups
  Description
Merci Retriever Patients who were randomized to the Merci Retriever
Trevo Stentriever Patients who were randomized to the Trevo Stentriever
Total Total of all reporting groups

Baseline Measures
    Merci Retriever     Trevo Stentriever     Total  
Number of Participants  
[units: participants]
  90     88     178  
Age  
[units: years]
Mean ± Standard Deviation
  67.0  ± 14.7     67.4  ± 13.9     67.2  ± 14.2  
Gender  
[units: participants]
     
Female     54     48     102  
Male     36     40     76  
Region of Enrollment  
[units: participants]
     
United States     89     88     177  
Spain     1     0     1  



  Outcome Measures
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1.  Primary:   Primary Efficacy Endpoint   [ Time Frame: acute/procedural ]

2.  Primary:   Primary Safety Endpoint   [ Time Frame: within 24 hours of procedure ]

3.  Secondary:   Secondary Endpoint   [ Time Frame: 90 days ]

4.  Secondary:   Secondary Endpoint   [ Time Frame: procedure through 90 days ]

5.  Secondary:   Secondary Endpoint   [ Time Frame: 24 hours ]


  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 less than or equal to 60 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: Cindy Jahans, BSc, Clinical Research Manager
Organization: Concentric Medical / Stryker Neurovascular Inc
phone: 510-413-2268
e-mail: cindy.jahans@stryker.com


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT01270867     History of Changes
Other Study ID Numbers: DQR0038
Study First Received: January 4, 2011
Results First Received: November 20, 2013
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration