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Thrombectomy REvascularization of Large Vessel Occlusions in Acute Ischemic Stroke (TREVO) (TREVO)

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ClinicalTrials.gov Identifier: NCT01088672
Recruitment Status : Completed
First Posted : March 17, 2010
Results First Posted : July 17, 2015
Last Update Posted : July 17, 2015
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Ischemic Stroke
Intervention: Procedure: Mechanical Thrombectomy

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Acute Ischemic Stroke

Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke

Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.


Participant Flow:   Overall Study
    Acute Ischemic Stroke
STARTED   60 
COMPLETED   60 
NOT COMPLETED   0 



  Baseline Characteristics

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
Acute Ischemic Stroke

Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke

Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.


Baseline Measures
   Acute Ischemic Stroke 
Overall Participants Analyzed 
[Units: Participants]
 60 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.7  (13.4) 
Gender 
[Units: Participants]
 
Female   33 
Male   27 
Region of Enrollment 
[Units: Participants]
 
Spain   22 
Austria   16 
Germany   19 
Sweden   3 
NIHSS [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 17.7  (4.8) 
[1]

The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The maximum (worst) possible score is 42, with the minimum (best) score being a 0.

http://en.wikipedia.org/wiki/Nihss



  Outcome Measures

1.  Primary:   Revascularization Status   [ Time Frame: Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment ]

2.  Secondary:   Clinical Outcomes at 90 Days   [ Time Frame: 90-day ]

3.  Secondary:   Mortality at 90 Days   [ Time Frame: 90-day ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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: Amelia Saliba, AIS Clinical Program Manager
Organization: Stryker NV
phone: 510-413-2500
e-mail: aisstudies@stryker.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT01088672     History of Changes
Other Study ID Numbers: DQR0036
First Submitted: March 15, 2010
First Posted: March 17, 2010
Results First Submitted: February 12, 2015
Results First Posted: July 17, 2015
Last Update Posted: July 17, 2015