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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010971
Receipt No. R000012840
Scientific Title The Misago self-expanding rapid-exchange nitinol stent system for the treatment of femoropopliteal occlusive disease in a prospective multicenter observational trial
Date of disclosure of the study information 2013/06/15
Last modified on 2016/06/14

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Basic information
Public title The Misago self-expanding rapid-exchange nitinol stent system for the treatment of femoropopliteal occlusive disease in a prospective multicenter observational trial

Acronym Misago Japan Registry
Scientific Title The Misago self-expanding rapid-exchange nitinol stent system for the treatment of femoropopliteal occlusive disease in a prospective multicenter observational trial

Scientific Title:Acronym Misago Japan Registry
Region
Japan

Condition
Condition peripheral artery disease(femoropopliteal artery)
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The safety and efficacy for the treatment of femoropopliteal occlusive disease in a prospective multicenter observational trial with Misago self-expanding rapid-exchange nitinol stent system
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Primary patency of 12months after procedure
Key secondary outcomes All cause mortality
Myocardial infarction
Stroke
Freedom from revascularization
Freedom from bypass surgery
Freedom from major amputation
Symptomatic improvement
Inprovement of Ankle Brachial index
Stent thrombosis rate
Stent fracture rate
Technical successful rate
Procedure complications

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.ischemic change due femoropopliteal artery occlusive disease
2.Rutherford classification category 2 to 5
3.Rest or stressed ankle brachial index<0.9
Key exclusion criteria 1.no need for stent inplantation
2.life expectancy is two years or less
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Yokoi
Organization Kishiwada Tokushukai Hospital
Division name Cardiology
Zip code
Address 4-27-1 Kamoricho, Kishiwada City, Osaka, Japan
TEL 072-445-9915
Email masahiko-fujihara@themis.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaori Shimogama
Organization Japan Endovascular Treatment Conference
Division name Japan Endovascular Treatment Conference
Zip code
Address 3-6-40 Momochihama Sawaraku Fukuoka
TEL 092-834-2815
Homepage URL
Email misago.registry@j-et.jp

Sponsor
Institute Japan Endovascular Treatment Conference
Institute
Department

Funding Source
Organization Japan Endovascular Treatment Conference
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
2013 Year 06 Month 15 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 No longer recruiting
Date of protocol fixation
2013 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 15 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Follow up periods, 1,6,12,24 months

Management information
Registered date
2013 Year 06 Month 14 Day
Last modified on
2016 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012840

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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