Trevo® Retriever Registry Post Market Surveillance

Study Overview
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Brief Summary
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The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.

Detailed Description
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Trevo Retriever Registry is a prospective, open-label, consecutive enrollment, multi-center, international registry that may enroll a maximum of 2000 patients at up to 100 sites worldwide. Revascularization status will be assessed at the end of the procedure using the modified TICI (Thrombolysis in Cerebral Infarction)score. Additional data collection will include: Day 90 mRS assessment Day 90 all cause mortality Neurological deterioration at 24 hours post procedure, defined as a four or more point increase in the NIHSS score from the baseline score Rates of device and procedure related serious adverse events (AEs)

Official Title
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Stryker Neurovascular Trevo® Retriever Registry

Conditions
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Ischemic Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects experiencing acute ischemic stroke who are eligible for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus Trevo Retriever is the initial mechanical neuro-thrombectomy device used to remove the thrombus Signed Informed Consent obtained Subject willing to comply with the protocol follow-up requirements Anticipated life expectancy of at least 3 months Exclusion Criteria: The subject is participating in another mechanical neuro-thrombectomy device trial or any other clinical trial where the study procedure or treatment might confound the study end point.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mechanical thrombectomy, Trevo Retriever<br>Mechanical thrombectomy, Trevo Retriever | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score | The primary end point is revascularization based on modified Thrombolysis in Cerebral Infarction score (mTICI). Per protocol, successful revascularization is defined as having a modified TICI score ≥2b at the end of the procedure. Modified TICI Scale (mTICI Scale) Grade 0 - No Perfusion Grade 1 - Penetration with Minimal Perfusion Grade 2 - Partial Perfusion Grade 2a - Only partial filling (< 50%) of the entire vascular territory is visualized. Grade 2b - Filling of > 50% all of the expected vascular territory is visualized, but the filling is slower than normal. Grade 3 - Complete Perfusion | Post Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale (mRS) Assessment at 90 Days | The Modified Rankin Scale mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. A good clinical outcome = mRS scale 0-2. 0 - No symptoms at all. - No significant disability despite symptoms; able to carry out all usual duties and activities. - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. - Moderate disability; requiring some help, but able to walk without assistance. - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. - Severe disability; bedridden, incontinent and requiring constant nursing care and attention. - Dead. | 90 days | 
| All Cause Mortality | Overall mortality rate | 90 days | 
| Device and Procedure Related Serious Adverse Events (SAEs) | Rate of Device and Procedure related serious adverse events (SAE) | 90 days | 
| Neurological Deterioration at 24 Hours | Neurological Deterioration at 24 hours post procedure, defined as a 4 point or more increase in the NIHSS score over the baseline score. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, mechanical thrombectomy device, Retriever