NCT03496064

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

March 27, 2018

Last Update Submit

February 26, 2019

Conditions

Ischemic Stroke

Keywords

ThrombectomyEligibilityLarge vessel occlusion

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Successful reperfusion

    Day 0

  • Symptomatic intracranial hemorrhage

    Day 0-1

  • Time to reperfusion

    Day 0

  • Mortality

    Day 0-90

Study Arms (6)

Anterior circulation LVO patients with ASPECTS <6

Other: Successful reperfusion

Anterior circulation LVO patients with NIHSS<8

Posterior versus anterior circulation LVO patients

LVO patients with isolated PCA or ACA occlusions

Other: Successful reperfusion

Tandem lesions versus non-tandem lesion

Bridging vs Direct MT

Interventions

Successful reperfusionOTHER

Defined as modified Thrombolysis in Cerebral Infarction 2b/3

Anterior circulation LVO patients with ASPECTS <6LVO patients with isolated PCA or ACA occlusions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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).

You may not qualify if:

  • Current participation in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Neurology, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (6)

  • 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.

    PMID: 35989924DERIVED

  • 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.

    PMID: 32933420DERIVED

  • 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.

    PMID: 32847948DERIVED

  • 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.

    PMID: 31992179DERIVED

  • 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.

    PMID: 30944585DERIVED

  • 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.

    PMID: 30827193DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 12, 2018

Study Start

November 1, 2017

Primary Completion

April 15, 2018

Study Completion

December 30, 2018

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

CH(1)