Ischemic Stroke
Conditions
Keywords
ischemic stroke, mechanical thrombectomy device, Retriever
Brief summary
The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Detailed description
Trevo Retriever Registry is a prospective, open-label, consecutive enrollment, multi-center, international registry that may enroll a maximum of 2000 patients at up to 100 sites worldwide. Revascularization status will be assessed at the end of the procedure using the modified TICI (Thrombolysis in Cerebral Infarction)score. Additional data collection will include: 1. Day 90 mRS assessment 2. Day 90 all cause mortality 3. Neurological deterioration at 24 hours post procedure, defined as a four or more point increase in the NIHSS score from the baseline score 4. Rates of device and procedure related serious adverse events (AEs)
Interventions
None listed
Sponsors
Stryker Neurovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects experiencing acute ischemic stroke who are eligible for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus * Trevo Retriever is the initial mechanical neuro-thrombectomy device used to remove the thrombus * Signed Informed Consent obtained * Subject willing to comply with the protocol follow-up requirements * Anticipated life expectancy of at least 3 months
Exclusion criteria
* 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 |
|---|---|---|
| Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score | Post Procedure | The primary end point is revascularization based on modified Thrombolysis in Cerebral Infarction score (mTICI). Per protocol, successful revascularization is defined as having a modified TICI score ≥2b at the end of the procedure. Modified TICI Scale (mTICI Scale) Grade 0 - No Perfusion Grade 1 - Penetration with Minimal Perfusion Grade 2 - Partial Perfusion Grade 2a - Only partial filling (\< 50%) of the entire vascular territory is visualized. Grade 2b - Filling of \> 50% all of the expected vascular territory is visualized, but the filling is slower than normal. Grade 3 - Complete Perfusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) Assessment at 90 Days | 90 days | The Modified Rankin Scale mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. A good clinical outcome = mRS scale 0-2. 0 - No symptoms at all. 1. \- No significant disability despite symptoms; able to carry out all usual duties and activities. 2. \- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. 3. \- Moderate disability; requiring some help, but able to walk without assistance. 4. \- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5. \- Severe disability; bedridden, incontinent and requiring constant nursing care and attention. 6. \- Dead. |
| All Cause Mortality | 90 days | Overall mortality rate |
| Device and Procedure Related Serious Adverse Events (SAEs) | 90 days | Rate of Device and Procedure related serious adverse events (SAE) |
| Neurological Deterioration at 24 Hours | 24 hours | Neurological Deterioration at 24 hours post procedure, defined as a 4 point or more increase in the NIHSS score over the baseline score. |
Countries
Canada, Czechia, France, Germany, Hungary, Italy, Singapore, South Korea, Spain, Switzerland, Thailand, United States
Participant flow
Recruitment details
The Trevo Retriever Registry was a prospective, open-label, consecutive enrollment, multi-center international registry designed to enroll up to 2,000 subjects at up to 100 clinical sites worldwide.
Participants by arm
| Arm | Count |
|---|---|
| Trevo Retriever Mechanical thrombectomy, Trevo Retriever | 2,008 |
| Total | 2,008 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Assessment not completed | 3 |
| Overall Study | Death | 280 |
| Overall Study | Lost to Follow-up | 76 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Trevo Retriever | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1273 Participants | — |
| Age, Categorical Between 18 and 65 years | 735 Participants | — |
| Age, Continuous | 68.3 Years STANDARD_DEVIATION 14.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 8 participants | — |
| Region of Enrollment Czechia | 131 participants | — |
| Region of Enrollment France | 183 participants | — |
| Region of Enrollment Germany | 83 participants | — |
| Region of Enrollment Hungary | 28 participants | — |
| Region of Enrollment Italy | 12 participants | — |
| Region of Enrollment Singapore | 8 participants | — |
| Region of Enrollment South Korea | 27 participants | — |
| Region of Enrollment Spain | 134 participants | — |
| Region of Enrollment Switzerland | 9 participants | — |
| Region of Enrollment Thailand | 20 participants | — |
| Region of Enrollment United States | 1365 participants | — |
| Sex: Female, Male Female | 1041 Participants | — |
| Sex: Female, Male Male | 967 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 280 / 2,008 |
| other Total, other adverse events | 174 / 2,008 |
| serious Total, serious adverse events | 427 / 2,008 |
Outcome results
Primary
Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score
The primary end point is revascularization based on modified Thrombolysis in Cerebral Infarction score (mTICI). Per protocol, successful revascularization is defined as having a modified TICI score ≥2b at the end of the procedure. Modified TICI Scale (mTICI Scale) Grade 0 - No Perfusion Grade 1 - Penetration with Minimal Perfusion Grade 2 - Partial Perfusion Grade 2a - Only partial filling (\< 50%) of the entire vascular territory is visualized. Grade 2b - Filling of \> 50% all of the expected vascular territory is visualized, but the filling is slower than normal. Grade 3 - Complete Perfusion
Time frame: Post Procedure
Population: Intention to Treat (ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mechanical Thrombectomy, Trevo Retriever | Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score | 1863 Participants |
Secondary
All Cause Mortality
Overall mortality rate
Time frame: 90 days
Population: Intention to Treat (ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mechanical Thrombectomy, Trevo Retriever | All Cause Mortality | 280 Participants |
Secondary
Device and Procedure Related Serious Adverse Events (SAEs)
Rate of Device and Procedure related serious adverse events (SAE)
Time frame: 90 days
Population: Intention to Treat (ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mechanical Thrombectomy, Trevo Retriever | Device and Procedure Related Serious Adverse Events (SAEs) | 49 Participants |
Secondary
Modified Rankin Scale (mRS) Assessment at 90 Days
The Modified Rankin Scale mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. A good clinical outcome = mRS scale 0-2. 0 - No symptoms at all. 1. \- No significant disability despite symptoms; able to carry out all usual duties and activities. 2. \- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. 3. \- Moderate disability; requiring some help, but able to walk without assistance. 4. \- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5. \- Severe disability; bedridden, incontinent and requiring constant nursing care and attention. 6. \- Dead.
Time frame: 90 days
Population: Per Protocol. This endpoint includes patient with a baseline and 90 day assessment. 1997 participants that underwent mechanical thrombectomy with the Trevo retriever completed both assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mechanical Thrombectomy, Trevo Retriever | Modified Rankin Scale (mRS) Assessment at 90 Days | 1104 Participants |
Secondary
Neurological Deterioration at 24 Hours
Neurological Deterioration at 24 hours post procedure, defined as a 4 point or more increase in the NIHSS score over the baseline score.
Time frame: 24 hours
Population: Intention to Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mechanical Thrombectomy, Trevo Retriever | Neurological Deterioration at 24 Hours | 97 Participants |