UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004425 |
|---|---|
| Receipt number | R000005284 |
| Scientific Title | Retrospective Analysis for Femoropopliteal Stenting of 1000 limbs |
| Date of disclosure of the study information | 2010/10/21 |
| Last modified on | 2010/10/21 03:33:36 |
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Basic information
Public title
Retrospective Analysis for Femoropopliteal Stenting of 1000 limbs
Acronym
REAL-FP1000
Scientific Title
Retrospective Analysis for Femoropopliteal Stenting of 1000 limbs
Scientific Title:Acronym
REAL-FP1000
Region
| Japan |
Condition
Condition
Femoroppliteal disease
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficasy of self-expandable nitinol stent for femoropopliteal artery disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
primary patency (incidence of in-stent restenosis)in patients with and without cilostazol, chronic total occlusion or hemodialysis.
Angiographic patterns of in-stent restenosis
Key secondary outcomes
Secondary patency (re-occlusion rate)
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
patients who underwent successful EVT with a nitinol stent for de novo lesions
Key exclusion criteria
balloon angioplasty alone, restenotic lesions, use of a metallic stent, acute or subacute limb ischemia or history of lower extremities bypass surgery or endovascular treatment
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimitsu Soga |
Organization
Kokura Memorial ospital
Division name
cardiology
Zip code
Address
1-1 Kifune-machi Kokurakita-ku Kitakyushu
TEL
093-921-2231
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kokura Memorial Hospital
Division name
cardiology
Zip code
Address
TEL
093-921-2231
Homepage URL
Sponsor or person
Institute
Kokura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Kokura 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
小倉記念病院、関西労災病院、横浜市東部病院、仙台厚生病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 21 | 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
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
mean follow-up was 23 months
Management information
Registered date
| 2010 | Year | 10 | Month | 21 | Day |
Last modified on
| 2010 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005284
