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

NCT ID: NCT03496064

Last Updated: 2019-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-12-30

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).

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Anterior circulation LVO patients with ASPECTS <6

Successful reperfusion

Intervention Type OTHER

Defined as modified Thrombolysis in Cerebral Infarction 2b/3

Anterior circulation LVO patients with NIHSS<8

No interventions assigned to this group

Posterior versus anterior circulation LVO patients

No interventions assigned to this group

LVO patients with isolated PCA or ACA occlusions

Successful reperfusion

Intervention Type OTHER

Defined as modified Thrombolysis in Cerebral Infarction 2b/3

Tandem lesions versus non-tandem lesion

No interventions assigned to this group

Bridging vs Direct MT

No interventions assigned to this group

Interventions

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Successful reperfusion

Defined as modified Thrombolysis in Cerebral Infarction 2b/3

Intervention Type OTHER

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

Medtronic

INDUSTRY

Sponsor Role collaborator

CHU de Reims

OTHER

Sponsor Role collaborator

Hospital Vall d'Hebron

OTHER

Sponsor Role collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urs Fischer, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University Hospital Bern, Switzerland

Jan Gralla, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neuroradiology, University Hospital Bern, Switzerland

Locations

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Dept. of Neurology, Bern University Hospital

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 35989924 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32933420 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32847948 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31992179 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30944585 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30827193 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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231/2014

Identifier Type: -

Identifier Source: org_study_id

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