UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001269 |
|---|---|
| Receipt number | 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 13:37:02 |
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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
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
Sponsor or person
Institute
Shonan Kamakura General Hospital
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001483
