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

Completed

• Conditions: Ischemic Stroke
• Interventions: Other: Successful reperfusion

• Registration Number: NCT03496064
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-12
• Primary Completion: 2018-04-15
• Study Completion: 2018-12-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anterior circulation LVO patients with ASPECTS <6	Successful reperfusion	-
LVO patients with isolated PCA or ACA occlusions	Successful reperfusion	-

Primary Outcome Measures

Name	Time	Method
3 month functional independence	0-90 days	Number of patients with modified Rankin Scale \<=2
Favourable outcome	0-90 days	Number of patients with modified Rankin Scale \<=3
Excellent outcome	0-90 days	Number of patients with modified Rankin Scale \<=1

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dept. of Neurology, Bern University Hospital; 🇨🇭 Bern, Switzerland