Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry

Active, not recruiting

Phase N/A Results N/A

Update History

19 Apr '17
The Summary of Purpose was updated.
New
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.
Old
The purpose of this registry is to assess outcomes associated with the use of devices intended to restore blood flow in patients experiencing acute ischemic stroke.
The description was updated.
New
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.
Old
This is a registry evaluating the use of devices in patients diagnosed with an acute ischemic stroke. This registry may enroll up to 1000 patients.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
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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.
Old
Inclusion Criteria: - An informed consent or waiver - Patient has experienced an acute ischemic stroke - Treatment within 8 hours of stroke onset Exclusion Criteria: - Concurrent participation in a randomized study
4 Jun '16
Trial name was updated.
New
Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry
The description was updated.
New
This is a registry evaluating the use of devices in patients diagnosed with an acute ischemic stroke. This registry may enroll up to 1000 patients.
Old
This is a registry evaluating the use of devices in patients diagnosed with an acute ischemic stroke. This registry may enroll up to 1000 patients.
A location was updated in Delray Beach.
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The overall status was removed for Delray Medical Center.
A location was updated in Lexington.
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The overall status was removed for Neurosurgical Associates at Central Baptist.