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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030660
Receipt No. 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

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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
Email 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
Email t.ishihara31@gmail.com

Sponsor
Institute Kansai Rosai 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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034999

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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