N/A
N=984
Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke (STRATIS) Registry
Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02239640 ↗Enrolled (actual)
984
Serious AEs
1.9%
Results posted
Jun 2019
Primary outcome: Primary: Number of Participants Assessed for Revascularization With mTICI Grades 2b-3 — 724 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Medtronic Neurovascular Clinical Affairs
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Assessed for Revascularization With mTICI Grades 2b-3 |
724 | — |
| SECONDARY Incidence of Neurological Events of Interest |
91 | — |
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 neurothrombectomy devices intended to restore blood flow in patients experiencing acute ischemic stroke due to large intracranial vessel occlusion.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02239640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.