UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027897 |
|---|---|
| Receipt number | R000031952 |
| Scientific Title | Clinical study for Plasma Wire System (FIM-2) |
| Date of disclosure of the study information | 2017/06/23 |
| Last modified on | 2017/06/23 16:04:00 |
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Basic information
Public title
Clinical study for Plasma Wire System (FIM-2)
Acronym
FIM-2
Scientific Title
Clinical study for Plasma Wire System (FIM-2)
Scientific Title:Acronym
FIM-2
Region
| Japan |
Condition
Condition
Chronic total occlusion
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To achieve CTO penetration of antegrade wire more easily and more effectively and to confirm the safety, by penetrating into CTO inlet and true lumen or making re-entry using new RF generator with appropriate circuit, two kinds of PlasmaWire and penetration catheter W-OTW which has double OTW lumen. Moreover, to confirm the safety of PlasmaWire System in case of switching from antegrade approach to retrograde approach.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of the device, antegrade procedure success and patient success.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
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
-
Key exclusion criteria
-
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenya Nasu |
Organization
Toyohashi Heart Center
Division name
Cardiovascular Medicine
Zip code
Address
21-1 Gobudori, Oyama-Cho, Toyohashi, Aichi 441-8530 Japan
TEL
0532-37-3377
nasu@heart-center.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenya Nasu |
Organization
Toyohashi Heart Center
Division name
Cardiovascular Medicine
Zip code
Address
21-1 Gobudori, Oyama-Cho, Toyohashi, Aichi 441-8530 Japan
TEL
0532-37-3377
Homepage URL
nasu@heart-center.or.jp
Sponsor or person
Institute
Toyohashi Heart Center
Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Toyohashi Heart Center
Cardiovascular Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 06 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2017 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031952
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
