Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry
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|ClinicalTrials.gov Identifier: NCT02239640|
Recruitment Status : Completed
First Posted : September 15, 2014
Results First Posted : June 7, 2019
Last Update Posted : June 7, 2019
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||984 participants|
|Target Follow-Up Duration:||90 Days|
|Official Title:||Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry|
|Actual Study Start Date :||August 21, 2014|
|Actual Primary Completion Date :||October 7, 2016|
|Actual Study Completion Date :||October 7, 2016|
Medtronic NV market-released device
Patients experiencing an acute ischemic stroke due to a large vessel occlusion treated with a Medtronic Neurovascular market-released neurothrombectomy device.
- Number of Participants Assessed for Revascularization With mTICI Grades 2b-3 [ Time Frame: 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.
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)
- Incidence of Neurological Events of Interest [ Time Frame: up to 90 days post index procedure ]Evaluate events causing neurological deterioration (defined as ≥ 4 worsening points from baseline on the NIHSS scale)
- All-cause Mortality [ Time Frame: up to 90 days post index procedure ]
- Number of Participants With Good Functional Outcome (mRS 0-2) [ Time Frame: 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.
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead. (lower values represent less disability)
- Incidence of Device Related Serious Adverse Events [ Time Frame: 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.
- Time to Revascularization [ Time Frame: 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.
- Incidence of Procedure Related Serious Adverse Events [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239640
|Principal Investigator:||Nils Mueller-Kronast, M.D.||Advanced Neuroscience Network/Tenet South Florida|