UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026875 |
|---|---|
| Receipt number | R000030836 |
| Scientific Title | MISAGO stent Post Marketing Surveillance |
| Date of disclosure of the study information | 2017/04/05 |
| Last modified on | 2019/10/07 10:28:34 |
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Basic information
Public title
MISAGO stent Post Marketing Surveillance
Acronym
MISAGO PMS
Scientific Title
MISAGO stent Post Marketing Surveillance
Scientific Title:Acronym
MISAGO PMS
Region
| Japan |
Condition
Condition
Peripheral arterial disease of lower extremities by a stenotic or occlusive de novo lesion at SFA/PA
Classification by specialty
| Cardiology | Vascular surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety and efficacy,and long-term convalescence continuously of the MISAGO stent in the medical treatment every day
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Stent thrombosis, stent fracture and TLR incidence
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
nothing
Key exclusion criteria
nothing
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | nothing |
Organization
nothing
Division name
nothing
Zip code
Address
nothing
TEL
0465-81-4126
hideki_miwa@terumo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Youko Ogata |
Organization
Terumo Corporation
Division name
Clinical Development Department
Zip code
Address
1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan
TEL
0465-81-4126
Homepage URL
Youko_Ogata@terumo.co.jp
Sponsor or person
Institute
Terumo Corporation
Institute
Department
Personal name
Funding Source
Organization
Terumo Corporation
Organization
Division
Category of Funding Organization
Other
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 | 04 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
295
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2017 | Year | 04 | Month | 05 | Day |
Last modified on
| 2019 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030836
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
