Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trevo® Retriever | Device | Stent retriever procedure |
| 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) |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Populations met the inclusion/exclusion criteria above
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ZhongRong Miao, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing TianTan Hospital | Beijing | Beijing Municipality | 100050 | China | ||
| The Hospital of Shunyi District Beijing |
Enrollment occurs when the Trevo Retriever is deployed as the first mechanical neuro-thrombectomy device used to remove the thrombus. A Screening and Enrollment Log will be maintained by each site to document basic information such as date screened and reason for screen failures for subjects who fail to meet the study eligibility criteria. In order to avoid bias, every effort should be made to include all Trevo cases performed over a given duration of time in the registry.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm-Trevo® Retriever | All subjects who meet the inclusion/exclusion criteria and where Trevo Retriever is used as the initial mechanical thrombectomy device to remove thrombus from the neurovasculature in the setting of acute ischemic stroke. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Subject Demographics and Baseline Characteristics | Subjects' demographic characteristics will be summarized using descriptive statistic methods.- Continuous variables will be summarized by mean±SD, median, minimum and maximum. Categorical variables will be summarized by percentages and frequencies. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age will be summarized by percentages and frequencies. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Trevo Retriever was used as the primary device in all subjects. | Posted | Count of Participants | Participants | At the end of the neuro-thrombectomy procedure (Day 1) |
|
If the subjects completed their 90-day visit, the subjects were considered as alive at Day 90. If the subjects did not come for their Day 90 visit and died, the date of death was 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 were considered as alive at their Day 90. Otherwise, the subjects were counted as deaths before Day 90.
The Adverse Events will be monitored/accessed without regard to the specific Adverse Event Term.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Summary of All AEs and SAEs | All SAEs through Day 90 will be summarized by number of events, number of subjects with events and the percentages of subjects with events by the type of SAEs and by their relatedness. All AEs during procedure will be summarized by number of events, number of subjects with events and the percentages of the subjects with events by the type of AEs and by their relatedness. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nervous system disorders | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nervous system disorders | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fei Qin | Stryker Neurovascular | +8613524821775 | fei.qin@stryker.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 27, 2017 | Oct 15, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 15, 2018 | Oct 15, 2021 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
| 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 |
| Beijing |
| Beijing Municipality |
| 101300 |
| China |
| Qingyuan City People's Hospital | Qingyuan | Guangdong | 511518 | China |
| The Third Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050051 | China |
| Puyang Oilfield General Hospital | Puyang | Henan | 457001 | China |
| Linyi People's Hospital | Linyi | Shandong | 276003 | China |
| Qingdao Central Hospital | Qingdao | Shandong | 266042 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| Wenzhou Central Hospital | Wenzhou | Zhejiang | 325000 | China |
| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325027 | China |
| Count of Participants |
| Participants |
|
| Age, Continuous | Age will be summarized by mean±SD, median, minimum and maximum. | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary Effectiveness Outcome |
post-procedural eTICI score (≥2b) |
|
|
| Secondary | Day 90 mRS | good clinical outcomes defined as mRS of 0-2. | Posted | Count of Participants | Participants | Day 90 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Day 90 |
|
|
|
| Secondary | Neurological Deterioration | Four or more points increase in the NIHSS score from the baseline to 24 hours post procedure. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Day 90 |
|
|
|
| 11 |
| 201 |
| 11 |
| 201 |
| 5 |
| 201 |
| Infections and Infestations | Infections and infestations | Systematic Assessment |
|
| General disorders and administration site conditions | General disorders | Systematic Assessment |
|
| cardiac disorder | Cardiac disorders | Systematic Assessment |
|
Not provided