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

I

Insel Gruppe AG, University Hospital Bern

Status

Completed

Conditions

Ischemic Stroke

Treatments

Other: Successful reperfusion

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03496064
231/2014

Details and patient eligibility

About

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).

Enrollment

2,000 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

2,000 participants in 6 patient groups

Anterior circulation LVO patients with ASPECTS <6
Treatment:
Other: Successful reperfusion
Anterior circulation LVO patients with NIHSS<8
Posterior versus anterior circulation LVO patients
LVO patients with isolated PCA or ACA occlusions
Treatment:
Other: Successful reperfusion
Tandem lesions versus non-tandem lesion
Bridging vs Direct MT

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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