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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026875
Receipt No. R000030836
Scientific Title MISAGO stent Post Marketing Surveillance
Date of disclosure of the study information 2017/04/05
Last modified on 2019/10/07

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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
Email 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
Email Youko_Ogata@terumo.co.jp

Sponsor
Institute Terumo Corporation
Institute
Department

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
Email

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
URL(English) https://upload.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


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