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.
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.
Study Type
OBSERVATIONAL
Enrollment
201
Stent retriever procedure
Beijing TianTan Hospital
Beijing, Beijing Municipality, China
The Hospital of Shunyi District Beijing
Beijing, Beijing Municipality, China
Qingyuan City People's Hospital
Qingyuan, Guangdong, China
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.
Time frame: At the end of the neuro-thrombectomy procedure (Day 1)
Day 90 mRS
good clinical outcomes defined as mRS of 0-2.
Time frame: 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.
Time frame: Day 90
Neurological Deterioration
Four or more points increase in the NIHSS score from the baseline to 24 hours post procedure.
Time frame: 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.
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The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Puyang Oilfield General Hospital
Puyang, Henan, China
Linyi People's Hospital
Linyi, Shandong, China
Qingdao Central Hospital
Qingdao, Shandong, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Time frame: Day 90