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AzTrials

Acute Ischemic StrokeNCT03366818

New Stent Retriever, VERSI System for AIS

A study testing thrombectomy in people with Acute Ischemic Stroke, run by Kobe City General Hospital at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To confirm efficacy and safety of VERSI system for acute ischemic stroke Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
thrombectomy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteJapan
Study dates
21 Sep 2017to 31 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Kobe City General Hospital

    Kobe, Hyōgo

Other trials in Japan

About this study

Official title: Efficacy and Safety of VERSI System for Acute Ischemic Stroke

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

Read the detailed description

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

Being tested
thrombectomy
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • thrombectomyDevice

    mechanical thrombectomy

Study groups in NCT03366818
Study groupRoleWhat they receive
thrombectomyExperimentalthrombectomy by Versi system
Receives: Device: thrombectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of treatment-related severe adverse event

    symptomatic intracranial hemorrhage

    Measured: within 24 hours after procedure

Secondary outcomes (5)

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

    Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less

    Measured: 90days after procedure

  2. all intracralnial hemorrhage

    incidence of symptomatic and asymptomatic intracranial hemorrhage

    Measured: within 24 hours after procedure

  3. acceptable clinical outcome

    Proportion of subjects who have modified Rankin Scale (mRS) score of 2 or less or back to baseline of mRS

    Measured: 90days after procedure

  4. Severe adverse event related to device

    Any severe adverse event related to device

    Measured: within 24 hours after procedure

  5. recanalization ability of device

    rate of immediate reperfusion with the device upto 3 path measured using Thrombolysis in Cerebrovascular Infarction (TICI) score of 2b or greater

    Measured: immediatry after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2017
  2. Study start21 Sep 2017
  3. Primary completion31 Mar 2018
  4. Study completion31 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03366818
Sponsor's protocol ID
NEURO0001
Status last verified
Oct 2019
First submitted
11 Nov 2017
Last updated
15 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 30262657

Questions about this trial

What is this clinical trial studying?

A study testing thrombectomy in people with Acute Ischemic Stroke, run by Kobe City General Hospital at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of treatment-related severe adverse event (time frame: within 24 hours after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03366818, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.

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