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

Ischemic Stroke Clinical Trial

— BEYOND-SWIFT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03496064
• Other study ID #: 231/2014
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: February 2019
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• Successful reperfusion
Defined as modified Thrombolysis in Cerebral Infarction 2b/3

Locations

Country	Name	City	State
Switzerland	Dept. of Neurology, Bern University Hospital	Bern

Sponsors (8)

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

Country where clinical trial is conducted

Switzerland, 

Outcome

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