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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036228
Receipt No. R000041270
Scientific Title Multi center, Prospective registry of Tron FX thrombectomy for acute ischemic stroke
Date of disclosure of the study information 2019/03/17
Last modified on 2019/03/17

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Basic information
Public title Post market surveillance of Tron FX thrombectomy
for acute ischemic stroke
Acronym Tron FX PMA in Japan
Scientific Title Multi center, Prospective registry of Tron FX thrombectomy
for acute ischemic stroke
Scientific Title:Acronym Tron FX PMA in Japan
Region
Japan

Condition
Condition acute ischemic stroke
Classification by specialty
Neurology Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and efficacy of mechanical thrombectomy using Tron FX for acute ischemic stroke
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes mRS 0-2 at 90days after onset
Key secondary outcomes 1 successful recanalization, TICI 2b-3
2 symptomatic intracranial hemorrhage within 24 hours
3 mortality within 90 days after onset
4 mRS 0-2 or NIHSS 10 or more improvement or back to baseline mRS @90days after onset
5 procedure or device related severe adverse event
6 device failure

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria mechanical thrombectomy using Tron FX
Key exclusion criteria no limitation
Target sample size 240

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 650-0047
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 650-0047
Address 2-2 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL 078-302-4321
Homepage URL
Email chiakimk@cronos.ocn.ne.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization Kobe City Medical Center General Hospital
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) JIMRO CO LTD

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 078-302-432
Email n.sakai@siren.ocn.ne.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(宮城県)、筑波大学(茨城県)、京都大学(京都府)、兵庫医科大学(兵庫県)、神戸市立医療センター中央市民病院(兵庫県)、高知医療センター(高知県)、久留米大学(福岡県)、長崎大学(長崎県)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 17 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
2019 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational post market surveillance of mechanical thrombectomy using Tron FX stent retriever in Japan

Management information
Registered date
2019 Year 03 Month 17 Day
Last modified on
2019 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041270

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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