Ischemic Stroke
Conditions
Brief summary
The purpose of this registry is to assess clinical outcomes, and different factors that may affect these clinical outcomes such as systems of care, associated with the use of Covidien market-released neurothrombectomy devices intended to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion.
Detailed description
This is a prospective, multi-center, non-randomized, observational registry of acute ischemic stroke patients that have or will undergo treatment with the use of a Covidien market-released neurothrombectomy device (as the initial device used to remove the thrombus) within 8 hours of stroke symptom onset, at the discretion of the investigator and independent of participation in this registry. This registry may enroll up to 1000 patients.
Interventions
None listed
Sponsors
Medtronic Neurovascular Clinical Affairs
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient or patient's legally authorized representative has given Informed Consent according to Good Clinical Practices (GCP) and/or IRB and/or local or institutional policies. * Patient has experienced an acute ischemic stroke due to large intracranial vessel occlusion (with associated symptoms) and has been or will be treated with a Covidien market-released neurothrombectomy device, as the initial device used to remove the thrombus. * Treatment within 8 hours of stroke onset. * Pre-Stroke Modified Rankin Scale (mRS) score ≤ 1 (immediately) prior to stroke onset. * Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 8 and ≤ 30.
Exclusion criteria
* Concurrent participation in a multicenter randomized study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Assessed for Revascularization With mTICI Grades 2b-3 | Day 0-At the completion of the thrombectomy procedure | Assess revascularization using modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure. This scale determines the response of therapy for ischemic stroke based on angiographic appearances of the treated occluded vessel and the distal branches. Classification: grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches (higher values represent better outcomes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Neurological Events of Interest | up to 90 days post index procedure | Evaluate events causing neurological deterioration (defined as ≥ 4 worsening points from baseline on the NIHSS scale) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Device Related Serious Adverse Events | up to 90 days post index procedure | Any device-related serious adverse events associated with the use of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure. |
| All-cause Mortality | up to 90 days post index procedure | — |
| Incidence of Procedure Related Serious Adverse Events | up to 90 days post index procedure | Any procedure related serious adverse events occurring upon insertion of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure. |
| Time to Revascularization | Day 0-At the completion of the thrombectomy procedure | Arterial access puncture to revascularization measured in minutes. Lower values indicate shorter time to revascularization and vice versa. |
| Number of Participants With Good Functional Outcome (mRS 0-2) | 90 days post index procedure | Score based on modified Rankin Scale (mRS). The modified Rankin Scale (mRS) is a scale used to measure the degree of disability or dependence in daily activities of people who has had a stroke. Clasiffication: 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. (lower values represent less disability) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects enrolled | 984 |
| Total | 984 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 142 |
| Overall Study | Lost to Follow-up | 72 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 14.73 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 451 Participants | — |
| Sex: Female, Male Male | 533 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 142 / 984 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 19 / 984 |
Outcome results
Primary
Number of Participants Assessed for Revascularization With mTICI Grades 2b-3
Assess revascularization using modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure. This scale determines the response of therapy for ischemic stroke based on angiographic appearances of the treated occluded vessel and the distal branches. Classification: grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches (higher values represent better outcomes)
Time frame: Day 0-At the completion of the thrombectomy procedure
Population: 824 participants contributed to this analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Successful Revascularization | Number of Participants Assessed for Revascularization With mTICI Grades 2b-3 | 724 Participants |
Secondary
Incidence of Neurological Events of Interest
Evaluate events causing neurological deterioration (defined as ≥ 4 worsening points from baseline on the NIHSS scale)
Time frame: up to 90 days post index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Successful Revascularization | Incidence of Neurological Events of Interest | 91 Participants |
Other Pre-specified
All-cause Mortality
Time frame: up to 90 days post index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Successful Revascularization | All-cause Mortality | 142 Participants |
Other Pre-specified
Incidence of Device Related Serious Adverse Events
Any device-related serious adverse events associated with the use of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.
Time frame: up to 90 days post index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Successful Revascularization | Incidence of Device Related Serious Adverse Events | 2 Participants |
Other Pre-specified
Incidence of Procedure Related Serious Adverse Events
Any procedure related serious adverse events occurring upon insertion of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.
Time frame: up to 90 days post index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Successful Revascularization | Incidence of Procedure Related Serious Adverse Events | 17 Participants |
Other Pre-specified
Number of Participants With Good Functional Outcome (mRS 0-2)
Score based on modified Rankin Scale (mRS). The modified Rankin Scale (mRS) is a scale used to measure the degree of disability or dependence in daily activities of people who has had a stroke. Clasiffication: 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead. (lower values represent less disability)
Time frame: 90 days post index procedure
Population: 906 participants contributed to this analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Successful Revascularization | Number of Participants With Good Functional Outcome (mRS 0-2) | 512 Participants |
Other Pre-specified
Time to Revascularization
Arterial access puncture to revascularization measured in minutes. Lower values indicate shorter time to revascularization and vice versa.
Time frame: Day 0-At the completion of the thrombectomy procedure
Population: 939 patients were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Successful Revascularization | Time to Revascularization | 45.6 minutes | Standard Deviation 29 |