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.)
Study Type
OBSERVATIONAL
Enrollment
183
Medtronic Market-Released Neurothrombectomy Device
National Neuroscience Institute
Singapore, Singapore
National University Hospital
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
Prasat Neurology Institute
Bangkok, Thailand
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
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
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
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.
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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
Time frame: 24 hrs ± 8 hrs post procedure