Registry for Evaluating Outcome of Acute Ischemic Stroke Patients Treated With Mechanical Thrombectomy. (BEYOND-SWIFT)

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ClinicalTrials.gov Identifier: NCT03496064

Recruitment Status : Completed

First Posted : April 12, 2018

Last Update Posted : February 27, 2019

Sponsor:

Collaborators:

University Hospital, Toulouse

Technische Universität München

University of Toronto

Medtronic

CHU de Reims

Hospital Vall d'Hebron

University of Lausanne Hospitals

Information provided by (Responsible Party):

University Hospital Inselspital, Berne

Study Description

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).

Condition or disease	Intervention/treatment
Ischemic Stroke	Other: Successful reperfusion

Study Design

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Study Type :	Observational
Actual Enrollment :	2000 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	Bernese-European RegistrY for Ischemic Stroke Patients Treated Outside Current Guidelines With Neurothrombectomy Devices Using the SOLITAIRE™ FR With the Intention For Thrombectomy
Actual Study Start Date :	November 1, 2017
Actual Primary Completion Date :	April 15, 2018
Actual Study Completion Date :	December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

3 month functional independence [ Time Frame: 0-90 days ]
Number of patients with modified Rankin Scale <=2
Favourable outcome [ Time Frame: 0-90 days ]
Number of patients with modified Rankin Scale <=3
Excellent outcome [ Time Frame: 0-90 days ]
Number of patients with modified Rankin Scale <=1

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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).

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496064

Locations

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Switzerland
Dept. of Neurology, Bern University Hospital
Bern, Switzerland, 3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

University Hospital, Toulouse

Technische Universität München

University of Toronto

Medtronic

CHU de Reims

Hospital Vall d'Hebron

University of Lausanne Hospitals

Investigators

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Principal Investigator:	Urs Fischer, MD, MSc	Department of Neurology, University Hospital Bern, Switzerland
Principal Investigator:	Jan Gralla, MD	Department of Neuroradiology, University Hospital Bern, Switzerland

Study Documents (Full-Text)

Documents provided by University Hospital Inselspital, Berne:

Statistical Analysis Plan [PDF] March 20, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Meinel TR, Kaesmacher J, Mosimann PJ, Seiffge D, Jung S, Mordasini P, Arnold M, Goeldlin M, Hajdu SD, Olivé-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.

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, Krajíčková D, Alonso A, Costalat V, Hajdu SD, Olivé-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.

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.

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.

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Responsible Party:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT03496064
Other Study ID Numbers:	231/2014
First Posted:	April 12, 2018 Key Record Dates
Last Update Posted:	February 27, 2019
Last Verified:	February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	Yes

Keywords provided by University Hospital Inselspital, Berne:


Thrombectomy Eligibility Large vessel occlusion

Additional relevant MeSH terms:

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Stroke Ischemic Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases	Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Infarction Necrosis

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