Trevo® Retriever Registry (China)

Completed

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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
the Modified TICI(Thrombolysis in Cerebral Infarction) Scale at the End of Procedure	At the end of the neuro-thrombectomy procedure (Day 1)	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.

Secondary Outcome Measures

Name	Time	Method
Day 90 Mortality	Day 90	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 mRS	Day 90	good clinical outcomes defined as mRS of 0-2.
Rate of Study Device and Procedure Related SAE Through Day 90	Day 90	Rate of study device and procedure related serious adverse events (SAE) through Day 90.
Neurological Deterioration	24 hours	Four or more points increase in the NIHSS score from the baseline to 24 hours post procedure.

Locations (10): Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
🇨🇳
Hangzhou, Zhejiang, China
The Hospital of Shunyi District Beijing
🇨🇳
Beijing, Beijing, China
Qingyuan City People's Hospital
🇨🇳
Qingyuan, Guangdong, China
Linyi People's Hospital
🇨🇳
Linyi, Shandong, China
The Second Affiliated Hospital of Wenzhou Medical University
🇨🇳
Wenzhou, Zhejiang, China
Wenzhou Central Hospital
🇨🇳
Wenzhou, Zhejiang, China
The Third Hospital of Hebei Medical University
🇨🇳
Shijiazhuang, Hebei, China
Beijing TianTan Hospital
🇨🇳
Beijing, Beijing, China
Puyang Oilfield General Hospital
🇨🇳
Puyang, Henan, China
Qingdao Central Hospital
🇨🇳
Qingdao, Shandong, China