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New Stent Retriever, VERSI System for AIS

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ClinicalTrials.gov Identifier: NCT03366818
Recruitment Status : Enrolling by invitation
First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Nobuyuki Sakai, Kobe City General Hospital

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

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Device: thrombectomy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Efficacy and Safety of VERSI System for Acute Ischemic Stroke
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : April 30, 2018

Arm Intervention/treatment
Experimental: thrombectomy
thrombectomy by Versi system
Device: thrombectomy
mechanical thrombectomy




Primary Outcome Measures :
  1. incidence of treatment-related severe adverse event [ Time Frame: within 24 hours after procedure ]
    symptomatic intracranial hemorrhage


Secondary Outcome Measures :
  1. 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

  2. all intracralnial hemorrhage [ Time Frame: within 24 hours after procedure ]
    incidence of symptomatic and asymptomatic intracranial hemorrhage

  3. 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

  4. Severe adverse event related to device [ Time Frame: within 24 hours after procedure ]
    Any severe adverse event related to device

  5. 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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366818


Locations
Japan
Kobe City General Hospital
Kobe, Hyogo, Japan
Sponsors and Collaborators
Kobe City General Hospital
Investigators
Principal Investigator: Nobuyuki Sakai, MD DMSc Kobe City Medical Center General Hospital, Kobe, Japan

Responsible Party: Nobuyuki Sakai, Director, Neurosurgery, Kobe City General Hospital
ClinicalTrials.gov Identifier: NCT03366818     History of Changes
Other Study ID Numbers: NEURO0001
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes