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New Stent Retriever, VERSI System for AIS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03366818
Recruitment Status : Completed
First Posted : December 8, 2017
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Nobuyuki Sakai, Kobe City General Hospital

Tracking Information
First Submitted Date  ICMJE November 11, 2017
First Posted Date  ICMJE December 8, 2017
Last Update Posted Date October 15, 2019
Actual Study Start Date  ICMJE September 21, 2017
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2017)
incidence of treatment-related severe adverse event [ Time Frame: within 24 hours after procedure ]
symptomatic intracranial hemorrhage
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2017)
  • 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
  • all intracralnial hemorrhage [ Time Frame: within 24 hours after procedure ]
    incidence of symptomatic and asymptomatic intracranial hemorrhage
  • 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
  • Severe adverse event related to device [ Time Frame: within 24 hours after procedure ]
    Any severe adverse event related to device
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE New Stent Retriever, VERSI System for AIS
Official Title  ICMJE Efficacy and Safety of VERSI System for Acute Ischemic Stroke
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Acute Ischemic Stroke
Intervention  ICMJE Device: thrombectomy
mechanical thrombectomy
Study Arms  ICMJE Experimental: thrombectomy
thrombectomy by Versi system
Intervention: Device: thrombectomy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2017)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 31, 2019
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03366818
Other Study ID Numbers  ICMJE NEURO0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nobuyuki Sakai, Kobe City General Hospital
Study Sponsor  ICMJE Kobe City General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nobuyuki Sakai, MD DMSc Kobe City Medical Center General Hospital, Kobe, Japan
PRS Account Kobe City General Hospital
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP