UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030660 |
|---|---|
| Receipt number | R000034999 |
| Scientific Title | Randomized Comparison between Drug-Eluting Balloon and Plain Old Balloon Angioplasty for Jailed Side Branch: An Optical Coherence Tomography Study |
| Date of disclosure of the study information | 2018/01/03 |
| Last modified on | 2018/01/02 14:25:34 |
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Basic information
Public title
Randomized Comparison between Drug-Eluting Balloon and Plain Old Balloon Angioplasty for Jailed Side Branch: An Optical Coherence Tomography Study
Acronym
J-stone
Scientific Title
Randomized Comparison between Drug-Eluting Balloon and Plain Old Balloon Angioplasty for Jailed Side Branch: An Optical Coherence Tomography Study
Scientific Title:Acronym
J-stone
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of drug coated balloon for jailed side branch
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
The change of luminal area at the ostium of side branch assessed by optical coherence tomography 8 months after percutaneous coronary intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Using the drug-coated balloon for Kissing balloon technique for side branch.
Interventions/Control_2
Using the conventional balloon for Kissing balloon technique for side branch.
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 who had bifurcation lesion and need Kissing balloon technique for jailed side branch
Key exclusion criteria
Patients who couldn't receive Kissing balloon technique
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Ishihara |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular Center
Zip code
Address
3-1-69 Inabaso, Amagasaki, Hyogo
TEL
0664161221
t.ishihara31@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Ishihara |
Organization
Kansai Rosai Hospital
Division name
Cardiovascular Center
Zip code
Address
3-1-69 Inabaso, Amagasaki, Hyogo
TEL
0664161221
Homepage URL
t.ishihara31@gmail.com
Sponsor or person
Institute
Kansai Rosai 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
関西労災病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 07 | 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
| 2018 | Year | 01 | Month | 02 | Day |
Last modified on
| 2018 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034999
