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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03496064
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
University Hospital, Toulouse
Technische Universität München
University of Toronto
Medtronic
CHU de Reims
Hospital Vall d'Hebron
University of Lausanne Hospitals
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Study Description
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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).

Condition or disease Intervention/treatment
Ischemic Stroke Other: Successful reperfusion

Study Design
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Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Bernese-European RegistrY for Ischemic Stroke Patients Treated Outside Current Guidelines With Neurothrombectomy Devices Using the SOLITAIRE™ FR With the Intention For Thrombectomy
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : April 15, 2018
Actual Study Completion Date : December 30, 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
Anterior circulation LVO patients with ASPECTS <6 Other: Successful reperfusion
Defined as modified Thrombolysis in Cerebral Infarction 2b/3
Anterior circulation LVO patients with NIHSS<8
Posterior versus anterior circulation LVO patients
LVO patients with isolated PCA or ACA occlusions Other: Successful reperfusion
Defined as modified Thrombolysis in Cerebral Infarction 2b/3
Tandem lesions versus non-tandem lesion
Bridging vs Direct MT


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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).
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03496064


Locations
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Switzerland
Dept. of Neurology, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
University Hospital, Toulouse
Technische Universität München
University of Toronto
Medtronic
CHU de Reims
Hospital Vall d'Hebron
University of Lausanne Hospitals
Investigators
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Principal Investigator: Urs Fischer, MD, MSc Department of Neurology, University Hospital Bern, Switzerland
Principal Investigator: Jan Gralla, MD Department of Neuroradiology, University Hospital Bern, Switzerland
  Study Documents (Full-Text)

Documents provided by University Hospital Inselspital, Berne:
Statistical Analysis Plan  [PDF] March 20, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03496064    
Other Study ID Numbers: 231/2014
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University Hospital Inselspital, Berne:
Thrombectomy
Eligibility
Large vessel occlusion
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia