Registry for Evaluating Outcome of Acute Ischemic Stroke Patients Treated With Mechanical Thrombectomy. (BEYOND-SWIFT)
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ClinicalTrials.gov Identifier: NCT03496064 |
Recruitment Status :
Completed
First Posted : April 12, 2018
Last Update Posted : February 27, 2019
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Condition or disease | Intervention/treatment |
---|---|
Ischemic Stroke | Other: Successful reperfusion |
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 |

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 |
- 3 month functional independence [ Time Frame: 0-90 days ]Number of patients with modified Rankin Scale <=2
- Favourable outcome [ Time Frame: 0-90 days ]Number of patients with modified Rankin Scale <=3
- Excellent outcome [ Time Frame: 0-90 days ]Number of patients with modified Rankin Scale <=1
- Successful reperfusion [ Time Frame: Day 0 ]Number of patients with modified Thrombolysis in Cerebral Infarction 2b / 3
- Symptomatic intracranial hemorrhage [ Time Frame: Day 0-1 ]Number of patients with symptomatic intracranial hemorrhage according to ECASSII definition
- Time to reperfusion [ Time Frame: Day 0 ]Groin puncture to TICI2b/3
- Mortality [ Time Frame: Day 0-90 ]Number of patients with modified Rankin Scale 6

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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 |
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

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
Switzerland | |
Dept. of Neurology, Bern University Hospital | |
Bern, Switzerland, 3010 |
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 |
Documents provided by University Hospital Inselspital, Berne:
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 |
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 |
Thrombectomy Eligibility Large vessel occlusion |
Stroke Ischemic 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 Infarction Necrosis |