Trial Outcomes & Findings for Trevo® Retriever Registry (China) (NCT NCT03554850)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

201 participants

Primary outcome timeframe

At the end of the neuro-thrombectomy procedure (Day 1)

Results posted on

2022-05-27

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	201
Overall Study COMPLETED	190
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subject Demographics and Baseline Characteristics n=201 Participants 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.
Age, Categorical <=18 years	0 Participants n=201 Participants
Age, Categorical Between 18 and 65 years	111 Participants n=201 Participants
Age, Categorical >=65 years	90 Participants n=201 Participants
Age, Continuous	63 years n=201 Participants
Sex: Female, Male Female	142 Participants n=201 Participants
Sex: Female, Male Male	59 Participants n=201 Participants
Region of Enrollment China	201 participants n=201 Participants

PRIMARY outcome

Timeframe: At the end of the neuro-thrombectomy procedure (Day 1)

Population: The Trevo Retriever was used as the primary device in all subjects.

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.

Outcome measures

Outcome measures
Measure	Primary Effectiveness Outcome n=190 Participants post-procedural eTICI score (≥2b)
the Modified TICI(Thrombolysis in Cerebral Infarction) Scale at the End of Procedure	187 Participants

SECONDARY outcome

Timeframe: Day 90

good clinical outcomes defined as mRS of 0-2.

Outcome measures

Outcome measures
Measure	Primary Effectiveness Outcome n=201 Participants post-procedural eTICI score (≥2b)
Day 90 mRS	148 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Primary Effectiveness Outcome n=201 Participants post-procedural eTICI score (≥2b)
Day 90 Mortality	11 Participants

SECONDARY outcome

Timeframe: 24 hours

Four or more points increase in the NIHSS score from the baseline to 24 hours post procedure.

Outcome measures

Outcome measures
Measure	Primary Effectiveness Outcome n=195 Participants post-procedural eTICI score (≥2b)
Neurological Deterioration	15 Participants

SECONDARY outcome

Timeframe: Day 90

Rate of study device and procedure related serious adverse events (SAE) through Day 90.

Outcome measures

Outcome measures
Measure	Primary Effectiveness Outcome n=201 Participants post-procedural eTICI score (≥2b)
Rate of Study Device and Procedure Related SAE Through Day 90	0 Participants

Adverse Events

Overall Summary of All AEs and SAEs

Serious events: 11 serious events

Other events: 5 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Overall Summary of All AEs and SAEs n=201 participants at risk 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.
Nervous system disorders Nervous system disorders	2.5% 5/201 • 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.
Infections and infestations Infections and Infestations	1.5% 3/201 • 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.
General disorders General disorders and administration site conditions	1.00% 2/201 • 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.
Cardiac disorders cardiac disorder	0.50% 1/201 • 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.

Other adverse events

Other adverse events
Measure	Overall Summary of All AEs and SAEs n=201 participants at risk 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.
Nervous system disorders Nervous system disorders	2.5% 5/201 • 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.

Additional Information

Fei Qin

Stryker Neurovascular

Phone: +8613524821775

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER