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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035331
Receipt No. R000040252
Official scientific title of the study The best endovascular therapy for calcified femoropopliteal artery disease with interwoven nitinol stent backup strategy
Date of disclosure of the study information 2019/01/07
Last modified on 2018/12/21

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Basic information
Official scientific title of the study The best endovascular therapy for calcified femoropopliteal artery disease with interwoven nitinol stent backup strategy
Title of the study (Brief title) BURDOCK study
Region
Japan

Condition
Condition Symptomatic peripheral arterial disease with calcified superficial femoral artery occluded /stenotic lesion
Classification by specialty
Cardiology Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effectiveness of interwoven nitinol stent for calcified femoropopliteral arterial disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Binary restenosis rate at 1 year
Key secondary outcomes 1)All cause mortality
2)Clinical driven Target vessel revascularization
3)Conversion rate of bypass surgery
4)Acute limb ischemia
5)Major limb amputation rate
6)MALE
7)Presise stent implantation
8)restenosis rate at 2Y

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 1)Age older than 20
2)PAOD Rutherford Category 2-5
3)ABI lower than 0.9
4)Atheroscleritic lesion by DUS,CTA or MRA
5)calcified lesion
Key exclusion criteria 1)common femoral artery lesion
2)thrombotic lesion
3)anastasis of bypass graft
Target sample size 300

Research contact person
Name of lead principal investigator FUJIHARA MASAHIKO
Organization Kishiwada Tokushukai Hospital
Division name Cardiology
Address 4-27-1,Kamori-cho,Kishiwada City Osaka,Japan
TEL 0724459915
Email masahikofujihara@yahoo.co.jp

Public contact
Name of contact person FUJIHARA MASAHIKO
Organization Kishiwada Tokushukai Hospital
Division name Cardiology
Address 4-27-1,Kamori-cho,Kishiwada City Osaka,Japan
TEL 0724459915
Homepage URL
Email masahikofujihara@yahoo.co.jp

Sponsor
Institute Reserch association for lower limb artery revascularization
Institute
Department

Funding Source
Organization Century Medical Inc
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2019 Year 01 Month 07 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 17 Day
Anticipated trial start date
2019 Year 01 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Observational Study

Management information
Registered date
2018 Year 12 Month 21 Day
Last modified on
2018 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040252

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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