NCT03366818

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

6 months

First QC Date

November 11, 2017

Last Update Submit

October 14, 2019

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • incidence of treatment-related severe adverse event

    symptomatic intracranial hemorrhage

    within 24 hours after procedure

Secondary Outcomes (5)

  • recovery to independent life {modified Rankin score of 2 or less]

    90days after procedure

  • all intracralnial hemorrhage

    within 24 hours after procedure

  • acceptable clinical outcome

    90days after procedure

  • Severe adverse event related to device

    within 24 hours after procedure

  • recanalization ability of device

    immediatry after procedure

Study Arms (1)

thrombectomy

EXPERIMENTAL

thrombectomy by Versi system

Device: thrombectomy

Interventions

thrombectomyDEVICE

mechanical thrombectomy

thrombectomy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • known hemorrhagic tendency
  • arterial dissection, vasculitis
  • allergy for contrast media
  • other inappropriate condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kobe City General Hospital

Kobe, Hyōgo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 30262657DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Nobuyuki Sakai, MD DMSc

    Kobe City Medical Center General Hospital, Kobe, Japan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neurosurgery

Study Record Dates

First Submitted

November 11, 2017

First Posted

December 8, 2017

Study Start

September 21, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2019

Last Updated

October 15, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)