UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010971 |
|---|---|
| Receipt number | 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 | 2021/06/20 19:38:10 |
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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
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
misago.registry@j-et.jp
Sponsor or person
Institute
Japan Endovascular Treatment Conference
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 14 | Day |
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
| 2021 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012840
| 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 |
