UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042232
Receipt number R000048201
Scientific Title Mechanical thrombectomy using large aspiration catheter for acute ischemic stroke
Date of disclosure of the study information 2020/10/30
Last modified on 2020/10/26 11:05:22

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Basic information

Public title

Mechanical thrombectomy using large aspiration catheter for acute ischemic stroke

Acronym

REACT AIS Registry

Scientific Title

Mechanical thrombectomy using large aspiration catheter for acute ischemic stroke

Scientific Title:Acronym

REACT AIS Registry

Region

Japan


Condition

Condition

acute ischemic stroke

Classification by specialty

Neurology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate effects of thrombectomy using the REACT catheter for acute ischemic stroke

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

rate of recanalization more than mTICI2c

Key secondary outcomes

Efficacy
1 the best recanalization rate; more than mTICI2c
2 recanalization rate more than mTICI2c of the first thrombectomy
3 the best recanalization rate of the first thrombectomy
4 mRS 0-2 at 90days after intervention
Safety
1 rate of intracranial hemorrhage within 24hr after intervention
2 rate of symptomatic intracranial hemorrhage within 24hr after intervention
3 symptomatic vasospasm during intervention
4 device malfunction and advance event related device


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1 acute ischemic stroke patient treated mechanical thrombectomy using REACT and/or Solitaire FR within 24hrs after stroke.
2 occluded ICA, M1, M2-3, VA-BA

Key exclusion criteria

1 patient used non-approval devices
2 patient occluded 2 or more major vessels, ICA, VA-BA
3 patient don't want provide their medical informations to the study group

Target sample size

1380


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 Chiaki
Middle name
Last name Sakai

Organization

Kobe City Medical Center General Hospital

Division name

Center for Clinical Research and Innovation

Zip code

6500047

Address

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

TEL

078-302-4321

Homepage URL


Email

chiakmk@cronos.ocn.ne.jp


Sponsor or person

Institute

Kobe City Medical Center General Hospital

Institute

Department

Personal name



Funding Source

Organization

Medtronic Japan, Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



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

078-302-4321

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



Other administrative information

Date of disclosure of the study information

2020 Year 10 Month 30 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

2020 Year 10 Month 30 Day

Date of IRB


Anticipated trial start date

2020 Year 10 Month 30 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observation: mRS before onset, NIHSS before intervention, last healthy time, ASPECTS-CT, DWI, pc-ASPECTS, malfunction of the device, complication, NIHSS 24hrs after intervention, ICH, etc.


Management information

Registered date

2020 Year 10 Month 26 Day

Last modified on

2020 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048201


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name