Ischemic Stroke Clinical Trial
— BEYOND-SWIFTOfficial title:
Bernese-European RegistrY for Ischemic Stroke Patients Treated Outside Current Guidelines With Neurothrombectomy Devices Using the SOLITAIRE™ FR With the Intention For Thrombectomy
NCT number | NCT03496064 |
Other study ID # | 231/2014 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2017 |
Est. completion date | December 30, 2018 |
Verified date | February 2019 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 2000 |
Est. completion date | December 30, 2018 |
Est. primary completion date | April 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Dept. of Neurology, Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | CHU de Reims, Hospital Vall d'Hebron, Medtronic, Technische Universität München, University Hospital, Toulouse, University of Lausanne Hospitals, University of Toronto |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3 month functional independence | Number of patients with modified Rankin Scale <=2 | 0-90 days | |
Primary | Favourable outcome | Number of patients with modified Rankin Scale <=3 | 0-90 days | |
Primary | Excellent outcome | Number of patients with modified Rankin Scale <=1 | 0-90 days | |
Secondary | Successful reperfusion | Number of patients with modified Thrombolysis in Cerebral Infarction 2b / 3 | Day 0 | |
Secondary | Symptomatic intracranial hemorrhage | Number of patients with symptomatic intracranial hemorrhage according to ECASSII definition | Day 0-1 | |
Secondary | Time to reperfusion | Groin puncture to TICI2b/3 | Day 0 | |
Secondary | Mortality | Number of patients with modified Rankin Scale 6 | Day 0-90 |
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