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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.
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.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Ischemic Stroke Patients | Acute Ischemic Stroke (AIS) patients treated with Medtronic Market-Released Neurothrombectomy Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurothrombectomy | Device | Medtronic Market-Released Neurothrombectomy Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
| 90 Days Post Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
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AIS patients treated with a Medtronic market-released neurothrombectomy device.
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| Name | Affiliation | Role |
|---|---|---|
| Ka Sing Lawrence Wong, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Neuroscience Institute | Singapore | Singapore | ||||
| National University Hospital |
No individual participant data will be available.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2017 |
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| 24 hrs ± 8 hrs post procedure |
| 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. | 90 Days Post Procedure |
| 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. | 24 hrs ± 8 hrs post procedure |
| Singapore |
| Singapore |
| Singapore General Hospital | Singapore | Singapore |
| Prasat Neurology Institute | Bangkok | Thailand |
| Ramathibodi Hospital | Bangkok | Thailand |
| Siriraj Hospital | Bangkok | Thailand |
| 108 Military Central Hospital | Hanoi | Vietnam |
| Bach Mai Hospital | Hanoi | Vietnam |
| Ho Chi Minh City Medicine and Pharmacy University | Ho Chi Minh City | Vietnam |
| The People's 115 Hospital | Ho Chi Minh City | Vietnam |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||
| Pre-stroke mRS | The modified Rankin Scale (mRS) measures the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale ranges from 0-6, with lower values representing a better outcome. 0-No symptoms at all
| Count of Participants | Participants |
| |||||||||||||||||
| Baseline NIHSS | 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. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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
| Posted | Number | Participants | 90 Days Post Procedure |
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| 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. | Posted | Count of Participants | Participants | 24 hrs ± 8 hrs post procedure |
|
| |||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 90 Days Post Procedure |
|
| |||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 24 hrs ± 8 hrs post procedure |
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Adverse Events were collected from the point of consent through 90 day follow up visit.
For the purpose of this real-world registry, only the following Serious Adverse Events were collected:
Other [Not including Serious] Adverse Events were not monitored/assessed for this registry.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 14 | 183 | 14 | 183 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symptomatic Intracranial Hemorrhage (sICH) | Nervous system disorders | Systematic Assessment | Symptomatic Intracranial Hemorrhage (sICH) at 24 ± 8 hrs post procedure |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medtronic Neurovascular Clinical Affairs | Medtronic Neurovascular Clinical Affairs | 9498373700 | rs.nvclinicalprospr-sea@medtronic.com |
| Jul 2, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| mRS = 1 |
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| mRS = 2 |
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| mRS = 3 |
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| mRS = 4 |
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| mRS = 5 |
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| Not Done |
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