UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007016 |
|---|---|
| Receipt number | R000008252 |
| Scientific Title | Japanese BElow-the-knee Artery Treatment trial II for critical limb ischemia |
| Date of disclosure of the study information | 2012/01/05 |
| Last modified on | 2012/01/04 20:01:17 |
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Basic information
Public title
Japanese BElow-the-knee Artery Treatment trial II for critical limb ischemia
Acronym
J-BEAT II
Scientific Title
Japanese BElow-the-knee Artery Treatment trial II for critical limb ischemia
Scientific Title:Acronym
J-BEAT II
Region
| Japan |
Condition
Condition
Critical Limb Ischemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of endovascular therapy in critical limb ischemia with below-the-knee arterial disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
major adverse limb events
amputation-free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Percutaneous transcatheter angioplasty
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
Patients with critical limb ischemia who underwent endovascular therapy for below-the-knee artery
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Iida |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular center
Zip code
Address
3-1-69, Inabaso, Amagasaki city, Hyogo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular center
Zip code
Address
TEL
06-6416-1221
Homepage URL
Sponsor or person
Institute
Kansai Rosai 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
| 2012 | Year | 01 | Month | 05 | 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
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 04 | Day |
Last modified on
| 2012 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008252
