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

Bernese-European RegistrY for Ischemic Stroke Patients Treated Outside Current Guidelines With Neurothrombectomy Devices Using the SOLITAIRE™ FR With the Intention For Thrombectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03496064
Acronym
BEYOND-SWIFT
Enrollment
2000
Registered
2018-04-12
Start date
2017-11-01
Completion date
2018-12-30
Last updated
2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

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

OTHERSuccessful reperfusion

Defined as modified Thrombolysis in Cerebral Infarction 2b/3

Sponsors

University Hospital, Toulouse
CollaboratorOTHER
Technical University of Munich
CollaboratorOTHER
University of Toronto
CollaboratorOTHER
Medtronic
CollaboratorINDUSTRY
CHU de Reims
CollaboratorOTHER
Hospital Vall d'Hebron
CollaboratorOTHER
University of Lausanne Hospitals
CollaboratorOTHER
Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

MeasureTime frameDescription
3 month functional independence0-90 daysNumber of patients with modified Rankin Scale \<=2
Favourable outcome0-90 daysNumber of patients with modified Rankin Scale \<=3
Excellent outcome0-90 daysNumber of patients with modified Rankin Scale \<=1

Secondary

MeasureTime frameDescription
Successful reperfusionDay 0Number of patients with modified Thrombolysis in Cerebral Infarction 2b / 3
MortalityDay 0-90Number of patients with modified Rankin Scale 6
Symptomatic intracranial hemorrhageDay 0-1Number of patients with symptomatic intracranial hemorrhage according to ECASSII definition
Time to reperfusionDay 0Groin puncture to TICI2b/3

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026