UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015926 |
|---|---|
| Receipt number | R000017682 |
| Scientific Title | Multicenter prospective study of peripheral arterial disease treatment |
| Date of disclosure of the study information | 2014/12/12 |
| Last modified on | 2019/07/12 12:19:42 |
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Basic information
Public title
Multicenter prospective study of peripheral arterial disease treatment
Acronym
Multicenter prospective study of peripheral arterial disease treatment
Scientific Title
Multicenter prospective study of peripheral arterial disease treatment
Scientific Title:Acronym
Multicenter prospective study of peripheral arterial disease treatment
Region
| Japan |
Condition
Condition
Symptomatic peripheral arterial disease
Classification by specialty
| Surgery in general | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the current situation and prognosis of lower limb peripheral arterial disease treatment in Japan
We also analyze the results of any treatment statistically for the past cases of symptomatic peripheral arterial disease before this study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
･Patency rate of the target lesion
･Rate of target lesion revascularization
･Rate of target vessel revascularization
･Rate of target limb revascularization
･Survival rate and cardio and cerebrovascular event rate
Key secondary outcomes
･Frequency of acute and sub-acute thrombotic occlusion after treatment
･Frequency of acute limb ischemia
･Restenosis rate of each vessel
･Patency rate for each graft material
･Changes in ankle brachial index (ABI)
･Restenosis rate of the vessel after treatment
･Incidence of acute and sub-acute occlusion of the vessel after treatment
･Additional endovascular treatment (the repeat intervention rate of the target lesion, the target vessel, and the target limb)
･Frequency of additional surgical treatment (bypass, endarterectomy)
･Frequency of major or minor amputation
･Changes in WIQ (walking impairment questionnaire) and VascQOL
･Changes in Rutherford classification
･Changes in skin perfusion pressure (SPP)
･Frequency and number of debridement (including minor amputation)
･Incidence of recurrence or de novo wound after wound heal
･Changes of leg edema after revascularization
･Change in the Visual analogue scale (VAS)
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
･Patient diagnosed as symptomatic peripheral arterial disease and scheduled for revascularization
･For retrospective data accumulation, patients been diagnosed as symptomatic peripheral arterial disease and undergone revascularization before this study
Key exclusion criteria
･Patient who declined his/her consent
Target sample size
5500
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Obara |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
TEL
03-3353-1211
obara@z3.keio.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Matsubara |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
TEL
03-3353-1211
Homepage URL
matsubara@z6.keio.jp
Sponsor or person
Institute
Keio University
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
Keio University School of Medicine Institutional Review Board
Address
35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN
Tel
03-5363-3961
med-rinri-jimu@adst.keio.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
東京歯科大学市川総合病院（千葉県）、東京医科歯科大学医学部附属病院（東京都）、川崎市立川崎病院（神奈川県）、さいたま市立病院（埼玉県）、済生会横浜市東部病院（神奈川県）、東京医療センター（東京都）、平塚市民病院（神奈川県）、湘南鎌倉総合病院（神奈川県）、東京都済生会中央病院（東京都）、静岡赤十字病院（静岡県）、大久保病院（東京都）、東京慈恵会医科大学（東京都）、東京慈恵会医科大学附属柏病院（千葉県）、東北大学（宮城県）、浜松赤十字病院（静岡県）、国際医療福祉大学三田病院（東京都）、土浦協同病院（茨城県）、厚木市立病院（神奈川県）、新百合ヶ丘総合病院（神奈川県）、川崎医科大学附属病院（岡山県）、済生会八幡総合病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 12 | 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
| 2014 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2034 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study, Longitudinal study
Management information
Registered date
| 2014 | Year | 12 | Month | 12 | Day |
Last modified on
| 2019 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017682
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
