- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03366818
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
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
-
-
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
|
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
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.
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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