Real World Data in China
Conditions
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.
Interventions
DEVICETrevo® Retriever
Stent retriever procedure
Sponsors
Stryker Neurovascular
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Day 90 mRS | Day 90 | good clinical outcomes defined as mRS of 0-2. |
| 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. |
| Neurological Deterioration | 24 hours | Four or more points increase in the NIHSS score from the baseline to 24 hours post procedure. |
| 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. |
Countries
China
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 201 |
| Total | 201 |
Baseline characteristics
| Characteristic | Subject Demographics and Baseline Characteristics | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 90 Participants | — |
| Age, Categorical Between 18 and 65 years | 111 Participants | — |
| Age, Continuous | 63 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment China | 201 participants | — |
| Sex: Female, Male Female | 142 Participants | — |
| Sex: Female, Male Male | 59 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 11 / 201 |
| other Total, other adverse events | 5 / 201 |
| serious Total, serious adverse events | 11 / 201 |
Outcome results
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.
Time frame: At the end of the neuro-thrombectomy procedure (Day 1)
Population: The Trevo Retriever was used as the primary device in all subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Effectiveness Outcome | the Modified TICI(Thrombolysis in Cerebral Infarction) Scale at the End of Procedure | 187 Participants |
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.
Time frame: Day 90
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Effectiveness Outcome | Day 90 Mortality | 11 Participants |
Secondary
Day 90 mRS
good clinical outcomes defined as mRS of 0-2.
Time frame: Day 90
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Effectiveness Outcome | Day 90 mRS | 148 Participants |
Secondary
Neurological Deterioration
Four or more points increase in the NIHSS score from the baseline to 24 hours post procedure.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Effectiveness Outcome | Neurological Deterioration | 15 Participants |
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.
Time frame: Day 90
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Effectiveness Outcome | Rate of Study Device and Procedure Related SAE Through Day 90 | 0 Participants |