UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020480 |
|---|---|
| Receipt number | R000004356 |
| Scientific Title | REtrospective multicenter AnaLysis for FemoroPopliteal stent registry |
| Date of disclosure of the study information | 2016/01/07 |
| Last modified on | 2016/01/21 18:50:17 |
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Basic information
Public title
REtrospective multicenter AnaLysis for FemoroPopliteal stent registry
Acronym
REAL FP
Scientific Title
REtrospective multicenter AnaLysis for FemoroPopliteal stent registry
Scientific Title:Acronym
REAL FP
Region
| Japan |
Condition
Condition
Peripheral artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long term patency after nitinol stenting for femoro-popliteal lesion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary patency
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
symptoms due to the femoro-popliteal lesions (Rutherford 2-6) that affected the quality of life in spite of excises and medications.
Key exclusion criteria
We excluded those underwent angioplasty alone, those underwent stenting in the restenotic lesions and those presenting with acute or sub-acute limb ischemia with nitinol stents deployment. Patients whom we could not follow up at 6 month were also excluded from the analysis
Target sample size
742
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Iida |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular center
Zip code
Address
3-1-69, Inabaso, Amagasaki city, Hygo
TEL
06-6416-1221
iida.osa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Iida |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular center
Zip code
Address
3-1-69, Inabaso, Amagasaki city, Hyogo
TEL
06-6416-1221
Homepage URL
iida.osa@gmail.com
Sponsor or person
Institute
Kansai Rosai Hospital, cardiovascular center
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2016 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Long term results after endovascular therapy for patient presenting FP lesions were acceptable.
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
| 2004 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 05 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
The rate of surgical conversion was low.
Management information
Registered date
| 2016 | Year | 01 | Month | 07 | Day |
Last modified on
| 2016 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004356
