Stroke, Acute
Conditions
Brief summary
The purpose of this post-market registry is to collect real-world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia.
Detailed description
This is a prospective, multi-center, non-randomized, observational registry designed to collect real world data associated with the use of Medtronic market-released neurothrombectomy devices in acute ischemic stroke (AIS) patients from countries in South East Asia, including Singapore, Thailand and Vietnam. The primary objective of this registry is to assess clinical outcomes associated with the use of these devices in patients experiencing AIS due to large intracranial vessel occlusion within 8 hours of symptom onset. This registry may enroll up to 500 patients. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402 (j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402 (j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Interventions
DEVICENeurothrombectomy
Medtronic Market-Released Neurothrombectomy Device
Sponsors
Medtronic Neurovascular Clinical Affairs
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Subject/subject's legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements. 2. Subject has experienced an Acute Ischemic Stroke due to large intracranial vessel occlusion in at least one of the following intracranial vessels: internal carotid artery (ICA), M1 and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral arteries. 3. Subject has been or will be treated with a Medtronic market-released neurothrombectomy device as the initial device used to remove the thrombus. 4. Subject is willing to participate in a 90-day follow-up visit. 5. Treatment within 8 hours of stroke symptom onset (defined as stroke onset to access puncture).
Exclusion criteria
1\. Concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm or where the study procedure or treatment might confound the study analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) at 90 Days | 90 Days Post Procedure | mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Symptomatic Intracranial Hemorrhage (sICH) at 24 Hrs ± 8 Hrs Post Procedure | 24 hrs ± 8 hrs post procedure | Number of participants with symptomatic Intracranial hemorrhage (sICH) is defined as \>/= 4 points worsening from baseline on the National Institutes of Health Stroke Scale (NIHSS) associated with an image finding of intra-cranial hemorrhage (i.e., intracerebral or intraventricular) at 24 +/- 8 hrs post procedure. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment. |
| All-Cause Mortality Through 90 Days Post Procedure | 90 Days Post Procedure | Death through 90 days post procedure classified as neurological or non-neurological, with event leading to death. |
| Incidence of Emboli in New Territory (ENT) at 24 Hrs ± 8 Hrs Post Procedure | 24 hrs ± 8 hrs post procedure | Emboli in New Territory (ENT) is defined as embolization territories outside of the target downstream territory. |
Countries
Singapore, Thailand, Vietnam
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acute Ischemic Stroke Patients Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device due to large intracranial vessel occlusion within 8 hours of symptom onset. | 183 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 14 |
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Acute Ischemic Stroke Patients | — |
|---|---|---|
| Age, Continuous | 64.89 Years STANDARD_DEVIATION 13.67 | — |
| Baseline NIHSS | 15.20 units on a scale STANDARD_DEVIATION 5.88 | — |
| BMI | 23.13 kg/m^2 STANDARD_DEVIATION 3.91 | — |
| Pre-stroke mRS mRS = 0 | 147 Participants | — |
| Pre-stroke mRS mRS = 1 | 14 Participants | — |
| Pre-stroke mRS mRS = 2 | 2 Participants | — |
| Pre-stroke mRS mRS = 3 | 2 Participants | — |
| Pre-stroke mRS mRS = 4 | 2 Participants | — |
| Pre-stroke mRS mRS = 5 | 1 Participants | — |
| Pre-stroke mRS Not Done | 15 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 91 Participants | — |
| Sex: Female, Male Male | 92 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 14 / 183 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 14 / 183 |
Outcome results
Primary
Modified Rankin Scale (mRS) at 90 Days
mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. 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 Post Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acute Ischemic Stroke Patients | Modified Rankin Scale (mRS) at 90 Days | mRS = 0-2 | 112 Participants |
| Acute Ischemic Stroke Patients | Modified Rankin Scale (mRS) at 90 Days | mRS = 3-6 | 68 Participants |
Secondary
All-Cause Mortality Through 90 Days Post Procedure
Death through 90 days post procedure classified as neurological or non-neurological, with event leading to death.
Time frame: 90 Days Post Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acute Ischemic Stroke Patients | All-Cause Mortality Through 90 Days Post Procedure | 14 Participants |
Secondary
Incidence of Emboli in New Territory (ENT) at 24 Hrs ± 8 Hrs Post Procedure
Emboli in New Territory (ENT) is defined as embolization territories outside of the target downstream territory.
Time frame: 24 hrs ± 8 hrs post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acute Ischemic Stroke Patients | Incidence of Emboli in New Territory (ENT) at 24 Hrs ± 8 Hrs Post Procedure | 6 Participants |
Secondary
Number of Participants With Symptomatic Intracranial Hemorrhage (sICH) at 24 Hrs ± 8 Hrs Post Procedure
Number of participants with symptomatic Intracranial hemorrhage (sICH) is defined as \>/= 4 points worsening from baseline on the National Institutes of Health Stroke Scale (NIHSS) associated with an image finding of intra-cranial hemorrhage (i.e., intracerebral or intraventricular) at 24 +/- 8 hrs post procedure. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.
Time frame: 24 hrs ± 8 hrs post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acute Ischemic Stroke Patients | Number of Participants With Symptomatic Intracranial Hemorrhage (sICH) at 24 Hrs ± 8 Hrs Post Procedure | 14 Participants |