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Versi Retriever Approving Trial in Japan

Primary Purpose

Stroke, Acute

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

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring acute ischemic stroke

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute onset neurological sympto m related to occluded vessel
  • within 8 hours from onset to tre atment or within 24 hours from onset to treatment with imaging diagnosis
  • contra-indication or failed to int ravenous rt-PA
  • accessible occlusion at ICA, MC A, VA, BA, PCA
  • 5-30 of NIHSS
  • 0-2 of mRS before onset
  • obtain documented informed co ntent

Exclusion Criteria:

  • following condition; arterial diss ection, engird, inaccessible turtuousity, difficult access by 50% or m ore stenosis, acute intracranial hemorrhage, space occuping lesion or brain tumor, major early ischemic change in brain
  • occlude 2 major vessel territory
  • allege for contrast media,
  • abnormal PTT/APTT within 4 h ours intravenous heparin
  • hemorrhagic tendency or 3 or more INR with Warfarin administration
  • 30000cc or less of Platelet
  • 50mg/dL or less of blood sugar
  • uncontrolled blood pressure, 185mmHg or more at systolic, 110m mHg or more at diastolic
  • 90days or less life expancy
  • pregnant or lactating
  • join another trial of medicine or medical device
  • ineligible for trial

Sites / Locations

  • Kobe City Medical Center General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trial arm

Arm Description

Mechanical thrombectomy using Versi Retriever

Outcomes

Primary Outcome Measures

Good clinical outcome
modified Rankin Score is 0-2

Secondary Outcome Measures

Successful recanalization
TICI 2b-3
Successful recanalization
TICI 2b-3
Symptomatic and asymptomatic intracranial hemorrhage
NIHSS 4 or more worsened
Good clinical outcome 2
mRS 0-2 or NIHSS 10 or more improvement
sever advers event
device or procedure related

Full Information

First Posted
March 12, 2019
Last Updated
November 1, 2020
Sponsor
Kobe City General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04129203
Brief Title
Versi Retriever Approving Trial in Japan
Official Title
Multi Center, Prospective, Registry Trial of Versi Retriever Mechanical Thrombecomy for Acute Ischemic Stroke in Japan
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

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
Yes

5. Study Description

Brief Summary
This is Versi Retriever mechanical thrombectomy device approving study in Japan. Multi center, single arm, prospective registry trial. Physicians control trial, conducted my N Sakai, Kobe City Medical Center General Hospital.
Detailed Description
This is Versi Retriever mechanical thrombectomy device approving study in Japan. Multi center, single arm, prospective registry trial. Physicians control trial, conducted my N Sakai, Kobe City Medical Center General Hospital. 60 cases will be enrolled and 90 days follow up need. Primary endpoint is favorable clinical outcome, mRS 0-2. Secondary endpoint are mortality in 90days, immediate successful recanalization, TICI 2b-3, symptomatic intracranial hemorrhage, and any adverse event related to device and or procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
acute ischemic stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trial arm
Arm Type
Experimental
Arm Description
Mechanical thrombectomy using Versi Retriever
Intervention Type
Device
Intervention Name(s)
Versi Retriever thrombectomy
Intervention Description
Mechanical thrombectomy using Versi Retriever
Primary Outcome Measure Information:
Title
Good clinical outcome
Description
modified Rankin Score is 0-2
Time Frame
90days after procedure
Secondary Outcome Measure Information:
Title
Successful recanalization
Description
TICI 2b-3
Time Frame
at 3 passes of device in the procedure
Title
Successful recanalization
Description
TICI 2b-3
Time Frame
at end of procedure
Title
Symptomatic and asymptomatic intracranial hemorrhage
Description
NIHSS 4 or more worsened
Time Frame
at 24 hours after procedure
Title
Good clinical outcome 2
Description
mRS 0-2 or NIHSS 10 or more improvement
Time Frame
90days after procedure
Title
sever advers event
Description
device or procedure related
Time Frame
90days after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: acute onset neurological sympto m related to occluded vessel within 8 hours from onset to tre atment or within 24 hours from onset to treatment with imaging diagnosis contra-indication or failed to int ravenous rt-PA accessible occlusion at ICA, MC A, VA, BA, PCA 5-30 of NIHSS 0-2 of mRS before onset obtain documented informed co ntent Exclusion Criteria: following condition; arterial diss ection, engird, inaccessible turtuousity, difficult access by 50% or m ore stenosis, acute intracranial hemorrhage, space occuping lesion or brain tumor, major early ischemic change in brain occlude 2 major vessel territory allege for contrast media, abnormal PTT/APTT within 4 h ours intravenous heparin hemorrhagic tendency or 3 or more INR with Warfarin administration 30000cc or less of Platelet 50mg/dL or less of blood sugar uncontrolled blood pressure, 185mmHg or more at systolic, 110m mHg or more at diastolic 90days or less life expancy pregnant or lactating join another trial of medicine or medical device ineligible for trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nobuyuki Sakai, MD DMSc
Phone
81783024321
Ext
080
Email
n.sakai@siren.ocn.ne.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Chiaki Sakai, MD PhD
Phone
81783024321
Email
chiakimk@cronos.ocn.ne.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nobuyuki Sakai, MD DMSc
Organizational Affiliation
Kobe City Medical Center General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nobuyuki Sakai, MD, DMSc
Phone
81783024321
Ext
080
Email
n.sakai@siren.ocn.ne.jp
First Name & Middle Initial & Last Name & Degree
Chiaki Sakai, MD PhD
Phone
81783024321
Email
chiakimk@cronos.ocn.ne.jp
First Name & Middle Initial & Last Name & Degree
Yasushi Matsumoto, MD
First Name & Middle Initial & Last Name & Degree
Yuji Matsumaru, MD
First Name & Middle Initial & Last Name & Degree
Shinichi Yoshimura, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Versi Retriever Approving Trial in Japan

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