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UMIN ID: UMIN000015926

Registered date:12/12/2014

Multicenter prospective study of peripheral arterial disease treatment

Basic Information

Recruitment status	Open public recruiting
Health condition(s) or Problem(s) studied	Symptomatic peripheral arterial disease
Date of first enrollment	2014/12/12
Target sample size	5500
Countries of recruitment	Japan
Study type	Observational
Intervention(s)

TO Original Data: UMIN

Outcome(s)

Primary Outcome	･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
Secondary Outcome	･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)

Primary Outcome

･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

Secondary Outcome

･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)

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include 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
Exclude criteria	･Patient who declined his/her consent

Related Information

Primary Sponsor	Keio University Hospital Department of Surgery
Secondary Sponsor
Source(s) of Monetary Support	None
Secondary ID(s)

Contact

public contact
Name	Kentaro Matsubara
Address	35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN Japan
Telephone	03-5363-3802
E-mail	matsubara@z6.keio.jp
Affiliation	Keio University Department of Surgery
scientific contact
Name	Hideaki Obara
Address	35 Shinanomachi Shinjuku-ku, Tokyo, JAPAN Japan
Telephone	03-5363-3802
E-mail	obara@z3.keio.jp
Affiliation	Keio University Department of Surgery

TO Original Data: UMIN