New Stent Retriever, VERSI System for AIS

October 14, 2019 updated by: Nobuyuki Sakai, Kobe City General Hospital

Efficacy and Safety of VERSI System for Acute Ischemic Stroke

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hyogo
      • Kobe, Hyogo, Japan
        • Kobe City General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: thrombectomy
thrombectomy by Versi system
Device: thrombectomy
mechanical thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of treatment-related severe adverse event
Time Frame: within 24 hours after procedure
symptomatic intracranial hemorrhage
within 24 hours after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recovery to independent life {modified Rankin score of 2 or less]
Time Frame: 90days after procedure
Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less
90days after procedure
all intracralnial hemorrhage
Time Frame: within 24 hours after procedure
incidence of symptomatic and asymptomatic intracranial hemorrhage
within 24 hours after procedure
acceptable clinical outcome
Time Frame: 90days after procedure
Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less or back to baseline of mRS
90days after procedure
Severe adverse event related to device
Time Frame: within 24 hours after procedure
Any severe adverse event related to device
within 24 hours after procedure
recanalization ability of device
Time Frame: 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
immediatry after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kobe City General Hospital

Investigators

  • Principal Investigator: Nobuyuki Sakai, MD DMSc, Kobe City Medical Center General Hospital, Kobe, Japan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2017

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

November 11, 2017

First Submitted That Met QC Criteria

December 6, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 14, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEURO0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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