Ischemic Stroke
Conditions
Keywords
Thrombectomy, Eligibility, Large vessel occlusion
Brief summary
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).
Interventions
Defined as modified Thrombolysis in Cerebral Infarction 2b/3
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3 month functional independence | 0-90 days | Number of patients with modified Rankin Scale \<=2 |
| Favourable outcome | 0-90 days | Number of patients with modified Rankin Scale \<=3 |
| Excellent outcome | 0-90 days | Number of patients with modified Rankin Scale \<=1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful reperfusion | Day 0 | Number of patients with modified Thrombolysis in Cerebral Infarction 2b / 3 |
| Mortality | Day 0-90 | Number of patients with modified Rankin Scale 6 |
| Symptomatic intracranial hemorrhage | Day 0-1 | Number of patients with symptomatic intracranial hemorrhage according to ECASSII definition |
| Time to reperfusion | Day 0 | Groin puncture to TICI2b/3 |
Countries
Switzerland