Skip to main content
OpenTrials
Completed

NCT Number: NCT03496064

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Neurology, Bern University Hospital

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Successful reperfusion

Other

Defined as modified Thrombolysis in Cerebral Infarction 2b/3

Primary outcomes

  1. 3 month functional independence

    Time frame: 0-90 days

    Number of patients with modified Rankin Scale <=2

  2. Favourable outcome

    Time frame: 0-90 days

    Number of patients with modified Rankin Scale <=3

  3. Excellent outcome

    Time frame: 0-90 days

    Number of patients with modified Rankin Scale <=1

Secondary outcomes

  1. Successful reperfusion

    Time frame: Day 0

    Number of patients with modified Thrombolysis in Cerebral Infarction 2b / 3

  2. Symptomatic intracranial hemorrhage

    Time frame: Day 0-1

    Number of patients with symptomatic intracranial hemorrhage according to ECASSII definition

  3. Time to reperfusion

    Time frame: Day 0

    Groin puncture to TICI2b/3

  4. Mortality

    Time frame: Day 0-90

    Number of patients with modified Rankin Scale 6

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • CHU de Reims
  • Hospital Vall d'Hebron
  • Medtronic
  • Technical University of Munich
  • University Hospital, Toulouse
  • University of Lausanne Hospitals
  • University of Toronto

Registry information

Official study title

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

Acronym: BEYOND-SWIFT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2018
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.