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Latest updates to the Trevo® Retriever Registry Post Market Surveillance Clinical Trial page
- CheckyesterdayNo Change Detected
- Check2 days agoNo Change Detected
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- Check4 days agoChange DetectedThe study has expanded to 80 locations and has been updated from version v2.9.7 to v2.10.0.SummaryDifference0.4%
- Check5 days agoNo Change Detected
- Check11 days agoChange DetectedThe website has been updated to Revision v2.9.7 from v2.9.6.SummaryDifference0.1%
- Check25 days agoChange DetectedThe value of Revision has been updated from v2.9.5 to v2.9.6, indicating a recent revision in the content of the web page.SummaryDifference0.1%
- Check30 days agoChange DetectedThe value of Revision has been updated from v2.9.3 to v2.9.5, indicating a recent revision in the content of the web page.SummaryDifference0.1%
- Check31 days agoChange DetectedThe value of Revision has been updated from v2.9.1 to v2.9.3, indicating a recent revision in the content of the webpage.SummaryDifference0.1%
- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus related topics: Ischemic Stroke FDA Drug and Device Resources Show less Design Details Observational Model : Cohort Time Perspective: Prospective Target Follow-up Duration: 90 Days Groups and Interventions Groups/Cohorts Mechanical thrombectomy, Trevo Retriever Mechanical thrombectomy, Trevo Retriever Primary Outcome Measures Outcome Measure Measure Description Time Frame Revascularization Status Assessment at the End of the Trevo Retriever Procedure Using the Modified TICI Score The primary end point is revascularization based on modified Thrombolysis in Cerebral Infarction score (mTICI). Per protocol, successful revascularization is defined as having a modified TICI score ≥2b at the end of the procedure. Modified TICI Scale (mTICI Scale) Grade 0 - No Perfusion Grade 1 - Penetration with Minimal Perfusion Grade 2 - Partial Perfusion Grade 2a - Only partial filling (< 50%) of the entire vascular territory is visualized. Grade 2b - Filling of > 50% all of the expected vascular territory is visualized, but the filling is slower than normal. Grade 3 - Complete Perfusion Post Procedure Secondary Outcome Measures Outcome Measure Measure Description Time Frame Modified Rankin Scale (mRS) Assessment at 90 Days The Modified Rankin Scale mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. A good clinical outcome = mRS scale 0-2. 0 - No symptoms at all. - No significant disability despite symptoms; able to carry out all usual duties and activities. - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. - Moderate disability; requiring some help, but able to walk without assistance. - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. - Severe disability; bedridden, incontinent and requiring constant nursing care and attention. - Dead. 90 days All Cause Mortality Overall mortality rate 90 days Device and Procedure Related Serious Adverse Events (SAEs) Rate of Device and Procedure related serious adverse events (SAE) 90 days Neurological Deterioration at 24 Hours Neurological Deterioration at 24 hours post procedure, defined as a 4 point or more increase in the NIHSS score over the baseline score. 24 hours Keywords Provided by Stryker Neurovascular ischemic stroke mechanical thrombectomy device Retriever Additional Relevant MeSH Terms Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Ischemic Stroke Study Documents Provided by Stryker Neurovascular Study Protocol [ PDF , 1.05MB, 2016-03-24 ] No Statistical Analysis Plan (SAP) exists for this study. Revision: v2.9.1'. This change represents an update in the study details and outcomes related to ischemic stroke and mechanical thrombectomy using the Trevo Retriever device.SummaryDifference21%
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