Registry for Evaluating Outcome of Acute Ischemic Stroke Patients Treated With Mechanical Thrombectomy.

Study Overview
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Brief Summary
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The Bernese-European RegistrY for ischemic stroke patients treated Outside current guidelines with Neurothrombectomy Devices using the SOLITAIRE™ FR With the Intention For Thrombectomy (BEYOND-SWIFT) is a retrospective, multi-center, non-randomized observational study aims to investigate the safety and efficacy of a Medtronic market-released neurothrombectomy device (applied as initial devices used for intervention) in acute ischemic stroke patients who do not fulfill treatment eligibility according to current guidelines. Patients will be treated or were treated at the discretion of the investigator, independent of participation in this registry. Primary Analysis is the Impact of successful reperfusion on functional outcome at day 90 in patients presenting with large infarct cores (ASPECTS<6) or minor symptoms (NIHSS<8).

Official Title
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Bernese-European RegistrY for Ischemic Stroke Patients Treated Outside Current Guidelines With Neurothrombectomy Devices Using the SOLITAIRE™ FR With the Intention For Thrombectomy

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Other: Successful reperfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients or patient's legally authorized representative have given informed consent according to Good Clinical Practices (GCP) and/or IRB and/or local or institutional policies. The patient presents with an intracranial large vessel occlusion and therewith-related neurological symptoms and has been or will be treated with a Medtronic marketed-release neurothrombectomy device (applied as first device to attempt retrieving the thrombus). Exclusion Criteria: Current participation in another clinical trial
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anterior circulation LVO patients with ASPECTS <6<br> | Other: Successful reperfusion<br>* Defined as modified Thrombolysis in Cerebral Infarction 2b/3<br>|
| Anterior circulation LVO patients with NIHSS<8<br> | |
| Posterior versus anterior circulation LVO patients<br> | |
| LVO patients with isolated PCA or ACA occlusions<br> | Other: Successful reperfusion<br>* Defined as modified Thrombolysis in Cerebral Infarction 2b/3<br>|
| Tandem lesions versus non-tandem lesion<br> | |
| Bridging vs Direct MT<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 month functional independence | Number of patients with modified Rankin Scale <=2 | 0-90 days | 
| Favourable outcome | Number of patients with modified Rankin Scale <=3 | 0-90 days | 
| Excellent outcome | Number of patients with modified Rankin Scale <=1 | 0-90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful reperfusion | Number of patients with modified Thrombolysis in Cerebral Infarction 2b / 3 | Day 0 | 
| Symptomatic intracranial hemorrhage | Number of patients with symptomatic intracranial hemorrhage according to ECASSII definition | Day 0-1 | 
| Time to reperfusion | Groin puncture to TICI2b/3 | Day 0 | 
| Mortality | Number of patients with modified Rankin Scale 6 | Day 0-90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombectomy, Eligibility, Large vessel occlusion