New Stent Retriever, VERSI System for AIS

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Device: thrombectomy

• Registration Number: NCT03366818
• Lead Sponsor: Kobe City General Hospital

Brief Summary

To confirm efficacy and safety of VERSI system for acute ischemic stroke

Detailed Description

Efficacy; TICI 2a or more recanalization upto 3 pass of study device Safety; symptomatic intracranial hemorrhage within 24 hours of procedure

Study Timeline

• Study Start: 2017-09-21
• Study First Submitted: 2017-11-11
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-08
• Primary Completion: 2018-03-31
• Study Completion: 2019-03-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• onset to treat within 8 hours
• NIHSS 8 or more
• ASPECTS 5 or more
• Target vessel is ICA, MCA, VA, BA, PCA
• non-eligible or failed IV rt-PA

Exclusion Criteria

• known hemorrhagic tendency
• arterial dissection, vasculitis
• allergy for contrast media
• other inappropriate condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
thrombectomy	thrombectomy	thrombectomy by Versi system

Primary Outcome Measures

Name	Time	Method
incidence of treatment-related severe adverse event	within 24 hours after procedure	symptomatic intracranial hemorrhage

Secondary Outcome Measures

Name	Time	Method
all intracralnial hemorrhage	within 24 hours after procedure	incidence of symptomatic and asymptomatic intracranial hemorrhage
Severe adverse event related to device	within 24 hours after procedure	Any severe adverse event related to device
recanalization ability of device	immediatry after procedure	rate of immediate reperfusion with the device upto 3 path measured using Thrombolysis in Cerebrovascular Infarction (TICI) score of 2b or greater
recovery to independent life {modified Rankin score of 2 or less]	90days after procedure	Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less
acceptable clinical outcome	90days after procedure	Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less or back to baseline of mRS

Trial Locations

Locations (1)

Kobe City General Hospital; 🇯🇵 Kobe, Hyogo, Japan