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Recruitment status
Unique ID issued by UMIN UMIN000001269
Receipt No. R000001483
Scientific Title A prospective multicenter registry study of the treatment in patient with Japanese CLI
Date of disclosure of the study information 2008/07/28
Last modified on 2008/07/28

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Basic information
Public title A prospective multicenter registry study of the treatment in patient with Japanese CLI
Acronym A prospective multicenter registry study of the treatment in patient with Japanese CLI
Scientific Title A prospective multicenter registry study of the treatment in patient with Japanese CLI
Scientific Title:Acronym A prospective multicenter registry study of the treatment in patient with Japanese CLI
Region
Japan

Condition
Condition peripheral artery disease
Classification by specialty
Cardiology Vascular surgery Dermatology
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the efficacy of the treatment of the critical limb ischemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Limb sulvage rate at six month and twelve month
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with Critical Limb Ischemia rated as Rutherford Classification 4 or over,
Skin Purfusion Pressure, 30mmHg or below (With Ischemic ulcer, 40mmHg or below)
2) Ischemia of the lower extremity by imaging
3) Informed consent
Key exclusion criteria 1) Previous bypass,surgery or angioplasty
2) intolerance to antiplatelet agents
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke Miyashita
Organization Shonan Kamakura General Hospital
Division name Cardiovascular Division
Zip code
Address 1202-1 Yamazaki,Kamakura-city,Kanagawa,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shonan Kamakura General Hospital
Division name Cardiovascular Division
Zip code
Address
TEL 0467-46-1717
Homepage URL
Email

Sponsor
Institute Shonan Kamakura General Hospital
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
2008 Year 07 Month 28 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
Date of protocol fixation
2008 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Positive observation study for examining the effect of the medical treatment to Critical Limb Ischemia

Management information
Registered date
2008 Year 07 Month 28 Day
Last modified on
2008 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001483

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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