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

February 26, 2019 updated by: University Hospital Inselspital, Berne

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Dept. of Neurology, Bern University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 month functional independence
Time Frame: 0-90 days
Number of patients with modified Rankin Scale <=2
0-90 days
Favourable outcome
Time Frame: 0-90 days
Number of patients with modified Rankin Scale <=3
0-90 days
Excellent outcome
Time Frame: 0-90 days
Number of patients with modified Rankin Scale <=1
0-90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful reperfusion
Time Frame: Day 0
Number of patients with modified Thrombolysis in Cerebral Infarction 2b / 3
Day 0
Symptomatic intracranial hemorrhage
Time Frame: Day 0-1
Number of patients with symptomatic intracranial hemorrhage according to ECASSII definition
Day 0-1
Time to reperfusion
Time Frame: Day 0
Groin puncture to TICI2b/3
Day 0
Mortality
Time Frame: Day 0-90
Number of patients with modified Rankin Scale 6
Day 0-90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

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

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

April 15, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (Actual)

April 12, 2018

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 231/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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