UMIN-CTR Clinical Trial

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
Institute	Kobe City Medical Center General Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048201