Status:
COMPLETED
Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry
Lead Sponsor:
Medtronic Neurovascular Clinical Affairs
Conditions:
Ischemic Stroke
Eligibility:
All Genders
Brief Summary
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 ...
Detailed Description
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 neurothromb...
Eligibility Criteria
Inclusion
- 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
- Concurrent participation in a multicenter randomized study.
Key Trial Info
Start Date :
August 21 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 7 2016
Estimated Enrollment :
984 Patients enrolled
Trial Details
Trial ID
NCT02239640
Start Date
August 21 2014
End Date
October 7 2016
Last Update
June 7 2019
Active Locations (55)
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1
Banner University Medical Center
Phoenix, Arizona, United States, 85006
2
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
3
University of California Irvine
Irvine, California, United States, 92697
4
University of California Los Angeles
Los Angeles, California, United States, 90095