UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010986 |
|---|---|
| Receipt number | R000012860 |
| Scientific Title | Multicenter Retorospective analysisfor femoropopliteal lesion 2012 |
| Date of disclosure of the study information | 2013/06/20 |
| Last modified on | 2013/06/17 21:21:25 |
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Basic information
Public title
Multicenter Retorospective analysisfor femoropopliteal lesion 2012
Acronym
REAL-FP 2012
Scientific Title
Multicenter Retorospective analysisfor femoropopliteal lesion 2012
Scientific Title:Acronym
REAL-FP 2012
Region
| Japan |
Condition
Condition
peripheral artery disease for lower extremities
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
safety and efficasy of endovascular therapy for femoropopliteal artery disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30-day mortality
complication
primary patency
Key secondary outcomes
assisted-primary patency
secondary patency
overall survival
limb salvage rate
amputation-free survival
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
de novo femoropopliteal artery disease
Key exclusion criteria
acute onset ischemia
histry of revascularization
asymptomatic
unknown symptom
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimitsu Soga |
Organization
Kokura Memorial Hospital
Division name
Cardiology
Zip code
Address
3-2-1 Asano Kokurakita-ku Kitakyushu city
TEL
+81-93-511-2000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kokura Memorial Hospital
Division name
Cardiology
Zip code
Address
3-2-1 Asano Kokurakita-ku Kitakyushu city
TEL
Homepage URL
Sponsor or person
Institute
Kokkura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Kokkura Memorial Hospital
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
| 2013 | Year | 06 | Month | 20 | 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
| 2012 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2012 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 10 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
30-day mortality 1.1%
complication rate 7.8%
5-year primary patency 52.9%
Management information
Registered date
| 2013 | Year | 06 | Month | 17 | Day |
Last modified on
| 2013 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012860
