UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002346 |
|---|---|
| Receipt number | 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 | 2022/11/10 13:35:00 |
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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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shinkawabashi Hospital
Division name
Cardiology
Zip code
Address
TEL
Homepage URL
koyama@shinkawabashi.or.jp
Sponsor or person
Institute
Shinkawabashi Hospital, Cardiovascular center
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
Address
Tel
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
Completed
Date of protocol fixation
| 2009 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2009 | Year | 03 | Month | 21 | Day |
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
| 2022 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002877
