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New Stent Retriever, VERSI System for AIS

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
thrombectomy
Sponsored by
Kobe City General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Acute Ischemic Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kobe City General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

thrombectomy

Arm Description

thrombectomy by Versi system

Outcomes

Primary Outcome Measures

incidence of treatment-related severe adverse event
symptomatic intracranial hemorrhage

Secondary Outcome Measures

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

Full Information

First Posted
November 11, 2017
Last Updated
October 14, 2019
Sponsor
Kobe City General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03366818
Brief Title
New Stent Retriever, VERSI System for AIS
Official Title
Efficacy and Safety of VERSI System for Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kobe City General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
thrombectomy
Arm Type
Experimental
Arm Description
thrombectomy by Versi system
Intervention Type
Device
Intervention Name(s)
thrombectomy
Intervention Description
mechanical thrombectomy
Primary Outcome Measure Information:
Title
incidence of treatment-related severe adverse event
Description
symptomatic intracranial hemorrhage
Time Frame
within 24 hours after procedure
Secondary Outcome Measure Information:
Title
recovery to independent life {modified Rankin score of 2 or less]
Description
Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less
Time Frame
90days after procedure
Title
all intracralnial hemorrhage
Description
incidence of symptomatic and asymptomatic intracranial hemorrhage
Time Frame
within 24 hours after procedure
Title
acceptable clinical outcome
Description
Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less or back to baseline of mRS
Time Frame
90days after procedure
Title
Severe adverse event related to device
Description
Any severe adverse event related to device
Time Frame
within 24 hours after procedure
Title
recanalization ability of device
Description
rate of immediate reperfusion with the device upto 3 path measured using Thrombolysis in Cerebrovascular Infarction (TICI) score of 2b or greater
Time Frame
immediatry after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nobuyuki Sakai, MD DMSc
Organizational Affiliation
Kobe City Medical Center General Hospital, Kobe, Japan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kobe City General Hospital
City
Kobe
State/Province
Hyogo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30262657
Citation
Sakai N, Imamura H, Adachi H, Tani S, Tokunaga S, Funatsu T, Suzuki K, Adachi H, Sasaki N, Kawabata S, Akiyama R, Horiuchi K, Ohara N, Kono T, Fujiwara S, Kaneko N, Tateshima S. First-in-man experience of the Versi Retriever in acute ischemic stroke. J Neurointerv Surg. 2019 Mar;11(3):296-299. doi: 10.1136/neurintsurg-2018-014040. Epub 2018 Sep 27.
Results Reference
derived

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New Stent Retriever, VERSI System for AIS

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