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OpenTrials
Completed

NCT Number: NCT03366818

New Stent Retriever, VERSI System for AIS

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

Completed

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kobe City General Hospital

Kobe, Hyōgo, Japan

About this study

Efficacy; TICI 2a or more recanalization upto 3 pass of study device Safety; symptomatic intracranial hemorrhage within 24 hours of procedure

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thrombectomy

Device

mechanical thrombectomy

Primary outcomes

  1. incidence of treatment-related severe adverse event

    Time frame: within 24 hours after procedure

    symptomatic intracranial hemorrhage

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kobe City General Hospital

Other

Registry information

Official study title

Efficacy and Safety of VERSI System for Acute Ischemic Stroke

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Dec 8, 2017
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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