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
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
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
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
