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| Name | Class |
|---|---|
| University Hospital, Toulouse | OTHER |
| Technical University of Munich | OTHER |
| University of Toronto | OTHER |
| Medtronic |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior circulation LVO patients with ASPECTS <6 |
| ||
| Anterior circulation LVO patients with NIHSS<8 | |||
| Posterior versus anterior circulation LVO patients | |||
| LVO patients with isolated PCA or ACA occlusions |
| ||
| Tandem lesions versus non-tandem lesion | |||
| Bridging vs Direct MT |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Successful reperfusion | Other | Defined as modified Thrombolysis in Cerebral Infarction 2b/3 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with large-vessel occlusion acute ischemic stroke subjected to endovascular treatment using a Medtronic market-released neurothrombectomy device (applied as initial devices used for intervention).
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| Name | Affiliation | Role |
|---|---|---|
| Urs Fischer, MD, MSc | Department of Neurology, University Hospital Bern, Switzerland | Principal Investigator |
| Jan Gralla, MD | Department of Neuroradiology, University Hospital Bern, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Neurology, Bern University Hospital | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35989924 | Derived | Mujanovic A, Kurmann CC, Dobrocky T, Olive-Gadea M, Maegerlein C, Pierot L, Mendes Pereira V, Costalat V, Psychogios M, Michel P, Beyeler M, Piechowiak EI, Seiffge DJ, Mordasini P, Arnold M, Gralla J, Fischer U, Kaesmacher J, Meinel TR; BEYOND-SWIFT Investigators. Bridging intravenous thrombolysis in patients with atrial fibrillation. Front Neurol. 2022 Aug 3;13:945338. doi: 10.3389/fneur.2022.945338. eCollection 2022. | |
| 32933420 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2018 | Mar 27, 2018 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| INDUSTRY |
| CHU de Reims | OTHER |
| Hospital Vall d'Hebron | OTHER |
| University of Lausanne Hospitals | OTHER |
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| 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 |
| Derived |
| Kaesmacher J, Maamari B, Meinel TR, Piechowiak EI, Mosimann PJ, Mordasini P, Goeldlin M, Arnold M, Dobrocky T, Boeckh-Behrens T, Berndt M, Michel P, Requena M, Benali A, Pierot L, Mendes Pereira V, Boulouis G, Brehm A, Sporns PB, Ospel JM, Gralla J, Fischer U; BEYOND-SWIFT Investigators. Effect of Pre- and In-Hospital Delay on Reperfusion in Acute Ischemic Stroke Mechanical Thrombectomy. Stroke. 2020 Oct;51(10):2934-2942. doi: 10.1161/STROKEAHA.120.030208. Epub 2020 Sep 16. |
| 32847948 | Derived | Meinel TR, Kaesmacher J, Mosimann PJ, Seiffge D, Jung S, Mordasini P, Arnold M, Goeldlin M, Hajdu SD, Olive-Gadea M, Maegerlein C, Costalat V, Pierot L, Schaafsma JD, Fischer U, Gralla J. Association of initial imaging modality and futile recanalization after thrombectomy. Neurology. 2020 Oct 27;95(17):e2331-e2342. doi: 10.1212/WNL.0000000000010614. Epub 2020 Aug 26. |
| 31992179 | Derived | Meinel TR, Kniepert JU, Seiffge DJ, Gralla J, Jung S, Auer E, Frey S, Goeldlin M, Mordasini P, Mosimann PJ, Nogueira RG, Haussen DC, Rodrigues GM, Uphaus T, L'Allinec V, Krajickova D, Alonso A, Costalat V, Hajdu SD, Olive-Gadea M, Maegerlein C, Pierot L, Schaafsma J, Suzuki K, Arnold M, Heldner MR, Fischer U, Kaesmacher J. Endovascular Stroke Treatment and Risk of Intracranial Hemorrhage in Anticoagulated Patients. Stroke. 2020 Mar;51(3):892-898. doi: 10.1161/STROKEAHA.119.026606. Epub 2020 Jan 29. |
| 30944585 | Derived | Meinel TR, Kaesmacher J, Mordasini P, Mosimann PJ, Jung S, Arnold M, Heldner MR, Michel P, Hajdu SD, Ribo M, Requena M, Maegerlein C, Friedrich B, Costalat V, Benali A, Pierot L, Gawlitza M, Schaafsma J, Pereira VM, Gralla J, Fischer U. Outcome, efficacy and safety of endovascular thrombectomy in ischaemic stroke according to time to reperfusion: data from a multicentre registry. Ther Adv Neurol Disord. 2019 Mar 27;12:1756286419835708. doi: 10.1177/1756286419835708. eCollection 2019. |
| 30827193 | Derived | Kaesmacher J, Chaloulos-Iakovidis P, Panos L, Mordasini P, Michel P, Hajdu SD, Ribo M, Requena M, Maegerlein C, Friedrich B, Costalat V, Benali A, Pierot L, Gawlitza M, Schaafsma J, Mendes Pereira V, Gralla J, Fischer U. Mechanical Thrombectomy in Ischemic Stroke Patients With Alberta Stroke Program Early Computed Tomography Score 0-5. Stroke. 2019 Apr;50(4):880-888. doi: 10.1161/STROKEAHA.118.023465. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |