UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036228 |
|---|---|
| Receipt number | 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 08:04:20 |
* 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
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
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
chiakimk@cronos.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
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
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
Value
https://center6.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 |
