Clinical trial NCT03554850: Trevo® Retriever Registry (China)
Official title: Trevo® Retriever Registry (China)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Real World Data in China
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2018-06-13
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Populations met the inclusion/exclusion criteria above

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18
2. 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
3. Trevo Retriever is planned to be the primary mechanical neuro-thrombectomy device to remove the thrombus
4. Subject or subject's legally authorized Representative (LAR) has signed the study Informed Consent Form
5. Subject willing to comply with the protocol follow-up requirements

Exclusion Criteria:

1. mRS \>2
2. Any known coagulopathy
3. Anticipated life expectancy less than 3 months
4. Known absolute contraindications to the use of required study medications or agents (e.g., heparin, aspirin, clopidogrel, radiographic contrast agents, etc.)
5. Preexisting neurological or psychiatric disease that would prevent complete the study required evaluations
6. 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 outcomes:
measure: the Modified TICI(Thrombolysis in Cerebral Infarction) Scale at the End of Procedure
timeFrame: At the end of the neuro-thrombectomy procedure (Day 1)
Secondary outcomes:
measure: Day 90 mRS
timeFrame: Day 90
measure: Day 90 Mortality
timeFrame: Day 90
measure: Neurological Deterioration
timeFrame: 24 hours
measure: Rate of Study Device and Procedure Related SAE Through Day 90
timeFrame: Day 90
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing TianTan Hospital
state: Beijing
city: Beijing
country: China
facility: The Hospital of Shunyi District Beijing
state: Beijing
city: Qingyuan
country: China
facility: Qingyuan City People's Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Puyang
country: China
facility: Puyang Oilfield General Hospital
state: Henan
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Central Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Beijing Tiantan Hospital
name: ZhongRong Miao, MD
role: PRINCIPAL_INVESTIGATOR
References: