UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034702 |
|---|---|
| Receipt number | R000039560 |
| Scientific Title | Long-term outcomes of endovascular treatment for peripheral artery disease in Kumamoto multicenter registry |
| Date of disclosure of the study information | 2018/10/30 |
| Last modified on | 2019/04/15 20:47:25 |
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Basic information
Public title
Long-term outcomes of endovascular treatment for peripheral artery disease in Kumamoto multicenter registry
Acronym
Kumamoto EVT registry
Scientific Title
Long-term outcomes of endovascular treatment for peripheral artery disease in Kumamoto multicenter registry
Scientific Title:Acronym
Kumamoto EVT registry
Region
| Japan |
Condition
Condition
peripheral artery disease
Classification by specialty
| Cardiology | Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We accumulate present data of endovascular treatment for peripheral arterial disease and compare the results between conventional therapeutic devices and novel ones. We also assess the difficulty of treatment by lesion properties and the risk of restenosis in multicenter. We assess and clarify the future therapeutic problems.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Target Vessel Revascularization:TVR
2. Improvement of maximun walk distance
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Symptomatic lower peripheral artery disease patients more than 20 years old who undergo endovascular treatment (EVT).
Key exclusion criteria
1) No consent for this study.
2) Scheduled bypass grafting or lower leg amputation.
3) Patients less than 20 years old.
4) Life expectancy less than 1 year.
5) Acute limb ischemia.
6) Patients who have the difficulty for use of contrast media due to allergy or severe renal dysfunction.
7) Patients who have the difficulty for anti-thrombotic therapy.
8) Patients who take part in the other study.
9) In case the chief researcher decides the enrolled patients is inappropriate for this study.
10) EVT for deep femoral artery only
11) Rutherford 6
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tsujita |
Organization
Kumamoto University
Division name
Department of Cardiovascular Medicine Graduate School of Medical Sciences
Zip code
8608556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City, Japan
TEL
81-96-373-5175
tsujita@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Fujisue |
Organization
Kumamoto University
Division name
Department of Cardiovascular Medicine Graduate School of Medical Sciences
Zip code
8608556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City, Japan
TEL
81-96-373-5175
Homepage URL
fujisues@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
none
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
the Human Ethics Review Committee of Kumamoto University Graduate School of Medicine
Address
1-1-1 Honjo, Chuo-ku, Kumamoto City, Japan
Tel
81-96-373-5657
byi-senshin@jimu.kumamoto-u.ac.jp
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
| 2018 | Year | 10 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2018 | Year | 10 | Month | 30 | Day |
Last modified on
| 2019 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039560
| 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 |
