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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
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acute Ischemic Stroke
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 60
Completed 60
Not Completed 0
Arm/Group Title Acute Ischemic Stroke
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
64.7  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
33
  55.0%
Male
27
  45.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants
Spain 22
Austria 16
Germany 19
Sweden 3
NIHSS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 60 participants
17.7  (4.8)
[1]
Measure Description:

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

1.Primary Outcome
Title Revascularization Status
Hide Description

Revascularization, defined as at least TICI 2a in the vascular territory treated at end of the neuro interventional procedure

Thrombolysis in Cerebral Infarction (TICI) grading system for perfusion (ie blood flow through a vessel) Grade 0:No Perfusion. No antegrade flow beyond the point of occlusion. Grade 1:Penetration With Minimal Perfusion. Grade 2:Partial Perfusion. Grade 2a:Only partial filling (<2/3) of the entire vascular territory is visualized.

Grade 2b:Complete filling of all of the expected vascular territory is visualized, but slower ...

Grade 3:Complete Perfusion. For complete info see Higashida RT, Furlan AJ, Roberts H, Tomsick T, Connors B et al. (2003) Trial design and reporting standards for intra-arterial cerebral thrombolysis for acute ischemic stroke. Stroke 34: e109-e137.10.1161/01.STR.0000082721.62796.09 PubMed: 12869717[PubMed]

Time Frame Post-procedure, immediate=at the end of the procedure, per last angiogram during treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute Ischemic Stroke
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of subjects TICI 2 or >
92
2.Secondary Outcome
Title Clinical Outcomes at 90 Days
Hide Description

Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days.

mRS 0-2 indicates functional independence 0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.

https://en.wikipedia.org/wiki/Modified_Rankin_Scale

Time Frame 90-day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute Ischemic Stroke
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of subjects with mrs 0-2
55
3.Secondary Outcome
Title Mortality at 90 Days
Hide Description All cause mortality through 90 days post procedure.
Time Frame 90-day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acute Ischemic Stroke
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
12
Time Frame 90 days
Adverse Event Reporting Description All events adjudicated by CEC
 
Arm/Group Title Acute Ischemic Stroke
Hide Arm/Group Description

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.

All-Cause Mortality
Acute Ischemic Stroke
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Acute Ischemic Stroke
Affected / at Risk (%) # Events
Total   12/60 (20.00%)    
Vascular disorders   
Death   12/60 (20.00%)  12
SICH  [1]  5/60 (8.33%)  5
Perforation   1/60 (1.67%)  1
Indicates events were collected by systematic assessment
[1]
Symptomatic intracerebral hemorrhage
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Acute Ischemic Stroke
Affected / at Risk (%) # Events
Total   3/60 (5.00%)    
Vascular disorders   
Asymptomatic hemorrhage   3/60 (5.00%)  3
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Amelia Saliba, AIS Clinical Program Manager
Organization: Stryker NV
Phone: 510-413-2500
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