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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002346
Receipt No. R000002877
Scientific Title Long-term prognosis of medical treatment on sick below-the-knee disease without critical limb ischemia
Date of disclosure of the study information 2009/08/18
Last modified on 2011/10/01

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Basic information
Public title Long-term prognosis of medical treatment on sick below-the-knee disease without critical limb ischemia
Acronym LOOK BK registry
Scientific Title Long-term prognosis of medical treatment on sick below-the-knee disease without critical limb ischemia
Scientific Title:Acronym LOOK BK registry
Region
Japan

Condition
Condition Arteriosclerotic obliterans
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe the clinical outcomes of the patients with below-the-knee artery disease but not critical limb ischemia
Basic objectives2 Others
Basic objectives -Others Clinical observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Death, Limb amputation, Critical limb ischemia, Myocardial infarction, Revascularization(Endovascular tharepy, Bypass surgery), Stroke
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ASO patients with =or>90% stenosis in anterior tibial artery or posterior tibial artery as below-the-knee artery disease(includes treatment history of above-the-knee artery, with/without symptoms after treatment of above-the-knee artery, without restenosis after treatment of above-the-knee artery)
Key exclusion criteria 1) No revascularization history of above-the-knee artery disease
2) Revascularization history of below-the-knee artery disease
3) Critical limb ischemia
4) Acute limb ischemia
5) Poor prognosis status (such as malignancy or low ejection fraction<30%)
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Koyama
Organization Shinkawabashi Hospital
Division name Cardiology
Zip code
Address 1-15 Shinkawabashi, Kawasaki-ku, Kawasaki, Kanagawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shinkawabashi Hospital
Division name Cardiology
Zip code
Address
TEL
Homepage URL
Email koyama@shinkawabashi.or.jp

Sponsor
Institute Shinkawabashi Hospital, Cardiovascular center
Institute
Department

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
Email

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
2009 Year 08 Month 18 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 Enrolling by invitation
Date of protocol fixation
2009 Year 03 Month 21 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2016 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Sampling for the study of efficacy and safety of endovascular therapy to non-critical limb ischemia with below-the-knee artery disease.

Management information
Registered date
2009 Year 08 Month 17 Day
Last modified on
2011 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002877

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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