Trevo® Retriever Registry (China)

Study Overview
=================
Brief Summary
-----------------
Trevo® Retriever Registry (China) is to assess real world performance of the FDA cleared Trevo Retriever intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke in China.

Detailed Description
-----------------
Trevo Registry (China) is a prospective, open-label, multi-center study, and it is the first Stryker China trial. This trial assesses real world performance of the Trevo® Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in subjects experiencing ischemic stroke. Total of 200 subjects among up to 15 sites in China local will participate in this trial. The primary endpoint is revascularization status assessment at the end of the procedure using the modified TICI score.

Official Title
-----------------
Trevo® Retriever Registry (China)

Conditions
-----------------
Real World Data in China

Intervention / Treatment
-----------------
* Device: Trevo® Retriever


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 Subjects experiencing acute ischemic stroke due to a large vessel occlusion who are eligible and suitable for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus Trevo Retriever is planned to be the primary mechanical neuro-thrombectomy device to remove the thrombus Subject or subject's legally authorized Representative (LAR) has signed the study Informed Consent Form Subject willing to comply with the protocol follow-up requirements Exclusion Criteria: mRS >2 Any known coagulopathy Anticipated life expectancy less than 3 months Known absolute contraindications to the use of required study medications or agents (e.g., heparin, aspirin, clopidogrel, radiographic contrast agents, etc.) Preexisting neurological or psychiatric disease that would prevent complete the study required evaluations 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Trevo® Retriever|Stent retriever procedure|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Modified TICI(Thrombolysis in Cerebral Infarction) Scale at the End of Procedure | The primary endpoint is measured using the modified TICI scale at the end of procedure.Success of primary endpoint was defined as a modified TICI score of 2b or better at the end of procedure. Primary endpoint will be analyzed by percentages, frequencies and the 95% confidence interval of the percentage of success. The 95% confidence interval will be calculated using ClopperPearson exact method. Note: Modified TICI score has 6 grades: 0(No Perfusion), 1(Penetration with Minimal Perfusion), 2(Partial Perfusion), 2a(Partial filling with <50% of the entire vascular territory is visualized), 2b(Partial filling with ≥50% of the entire vascular territory is visualized), 3(Complete Perfusion). Higher scores mean a better outcome. | At the end of the neuro-thrombectomy procedure (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day 90 mRS | good clinical outcomes defined as mRS of 0-2. | Day 90 | 
| Day 90 Mortality | If the subjects had completed their 90-day visit, the subjects will be considered as alive at Day 90. If the subjects did not come for their Day 90 visit and died, the date of death will be used to compare with the upper window of their Day 90 (90 + 14 days post procedure). If the subjects died after the upper window of their Day 90, the subjects will be considered as alive at their Day 90. Otherwise, the subjects will be counted as death before Day 90. | Day 90 | 
| Neurological Deterioration | Four or more points increase in the NIHSS score from the baseline to 24 hours post procedure. | 24 hours | 
| Rate of Study Device and Procedure Related SAE Through Day 90 | Rate of study device and procedure related serious adverse events (SAE) through Day 90. | Day 90 |