Status:

COMPLETED

New Stent Retriever, VERSI System for AIS

Lead Sponsor:

Kobe City General Hospital

Conditions:

Acute Ischemic Stroke

Eligibility:

All Genders

20+ years

Phase:

NA

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

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

September 21 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 31 2019

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT03366818

Start Date

September 21 2017

End Date

March 31 2019

Last Update

October 15 2019

Active Locations (1)

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1

Kobe City General Hospital

Kobe, Hyōgo, Japan