UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035632
Receipt number R000040591
Scientific Title Prospective, multi-center, trial of mechanical thrombectomy for acute ischemic stroke using Versi Retriever
Date of disclosure of the study information 2019/01/24
Last modified on 2020/10/22 06:13:35

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Prospective, multi-center, trial of mechanical thrombectomy for acute ischemic stroke using Versi Retriever

Acronym

Prospective trial of Versi Thrombectomy (VERTH)

Scientific Title

Prospective, multi-center, trial of mechanical thrombectomy for acute ischemic stroke using Versi Retriever

Scientific Title:Acronym

Prospective trial of Versi Thrombectomy (VERTH)

Region

Japan


Condition

Condition

acute ischemic stroke

Classification by specialty

Neurology Radiology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm efficacy and safety of mechanical thrombectomy for acute ischemic stroke using Versi retriever

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Good clinical outcome (modified Rankin score 0-2) and death 90days after procedure

Key secondary outcomes

1 successful recanalization after 3 passes of device
2 successful recanalization after procedure
3 new territory emolization related to procedure
4 symptomatic and asymtomatic intracranial hemorrhage 24 hours after procedure
5 symptomatic intracranial hemorrhage 24 hours after procedure
6 good clinical outcome (mRS 0-2 or 10 or more improvement of NIHSS) 90 days after procedure
7 severe adverse event related to device and procedure 90 days after procedure
8 mRS and NIHSS 90days after onset


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

mechanical thrombectomy using Versi Retriever

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1 acute onset neurological symptom related to occluded vessel
2 within 8 hours from onset to treatment or within 24 hours from onset to treatment with imaging diagnosis
3 contra-indication or failed to intravenous rt-PA
4 accessible occlusion at ICA, MCA, VA, BA, PCA
5 5-30 of NIHSS
6 0-2 of mRS before onset
7 obtain documented informed content

Key exclusion criteria

1 following condition; arterial dissection, engird, inaccessible turtuousity, difficult access by 50% or more stenosis, acute intracranial hemorrhage, space occping lesion or brain tumor, major early ischemic change in brain
2 occlude 2 major vessel territory
3 allege for contrast media,
4 abnormal PTT/APTT within 4 hours intravenous heparin
5 hemorrhagic tendency or 3 or more INR with Warfarin administration
6 30000cc or less of Platelet
7 50mg/dL or less of blood sugar
8 uncontrolled blood pressure, 185mmHg or more at systolic, 110mmHg or more at diastolic
9 90days or less life expancy
10 pregnant or lactating
11 join another trial of medicine or medical device
12 ineligible for trail

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Nobuyuki
Middle name
Last name Sakai

Organization

Kobe City Medical Center General Hospital

Division name

Neurosurgery

Zip code

6500047

Address

2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan

TEL

078-302-4321

Email

n.sakai@siren.ocn.ne.jp


Public contact

Name of contact person

1st name Nobuyuki
Middle name
Last name Sakai

Organization

Kobe City Medical Center General Hospital

Division name

Neurosurgery

Zip code

6500047

Address

2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan

TEL

078-302-4321

Homepage URL


Email

n.sakai@siren.ocn.ne.jp


Sponsor or person

Institute

Kobe City Medical Center General Hospital

Institute

Department

Personal name



Funding Source

Organization

Kobe City Medical Center General Hospital

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kobe City Medical Center General Hospital

Address

2-1-1 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan

Tel

0783024321

Email

rinken@kcho.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

広南病院、筑波大学、埼玉医科大学国際医療センター、京都大学、大阪医療センター、兵庫医科大学、神戸市立医療センター中央市民病院、


Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 24 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2018 Year 12 Month 06 Day

Date of IRB


Anticipated trial start date

2019 Year 02 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry

2021 Year 03 Month 31 Day

Date trial data considered complete

2021 Year 06 Month 30 Day

Date analysis concluded

2021 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 01 Month 23 Day

Last modified on

2020 Year 10 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040591


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name