UMIN-CTR Clinical Trial

Basic information
Public title	A 3D-OCT investigation into coronary artery bifurcation lesion stent implantation technique
Acronym	3D-OCT Bifurcation Registry
Scientific Title	A 3D-OCT investigation into coronary artery bifurcation lesion stent implantation technique
Scientific Title:Acronym	3D-OCT Bifurcation Registry
Region	Japan

Condition
Condition	Coronary artery bifurcation disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the optimal position of guide wire recrossing into jailed strut after stent deployment and demonstrate difficulties of bifurcation stenting utilizing 2D-/3D-OCT imaging for PCI treatment of coronary bifurcation lesions.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Post-implant in-stent images obtained via 2D-/3D-OCT will be analyzed to assess the following: 1)Patterns of jailed strut links at side branch site 2)Guide wire recrossing positions into jailed strut 3)Ratio of area of jailed strut cell to area of side branch ostium after dilatation of the side branch 4)Frequency and quantitative evaluation of occurrence of incomplete stent apposition(ISA)
Key secondary outcomes

Base
Study type

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	Maneuver
Interventions/Control_1	To investigate coronaary bifurcation stenting with 2D, 3D OCT imaging.
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)Patient who has a side branch at the stented site and the luminal diameter of the side branch is more than 2mm visually. 2)Patiet with a de novo lesion in which stent will be implanted. 3)Patient who is 20 years of age or older when he/she provides the informed consent.
Key exclusion criteria	1)Patient who has a stent restenosis lesion in which stent will be implanted. 2)Patient with cardiogenic shock. 3)Patient with a chronic total occlusion lesion. 4)Patient with CKD of Cr more than 1.5mg/dl. 5)Patient who is considered not appropriate to undergo PCI. 6)Patient who has any other medical condition that in the opinion of the investigator will not be appropriate to participate in the investigation.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Junya Shite, Takayuki Okamura
Organization	Osaka Saiseikai Nakatsu Hospital, Yamaguchi University Hospital
Division name	Cardiology
Zip code
Address	2-10-39, Shibata, Kita, Osaka
TEL	06-6372-0333
Email	ricegoalflow@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Junya Shite
Organization	Osaka Saiseikai Nakatsu Hospital
Division name	Cardiology
Zip code
Address	2-10-39, Shibata, Kita, Osaka
TEL	06-6372-0333
Homepage URL
Email	ricegoalflow@yahoo.co.jp

Sponsor
Institute	3D-OCT investigators
Institute
Department

Funding Source
Organization	3D-OCT Investigators
Organization
Division
Category of Funding Organization	Other
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	大阪府済生会中津病院（大阪府）、山口大学医学部附属病院（山口県）、山口県済生会山口総合病院（山口県）、済生会熊本病院（熊本県）、山口県立総合医療センター（山口県）、済生会横浜市東部病院（神奈川県）、福岡県済生会福岡総合病院（福岡県）、国立病院機構九州医療センター（福岡県）、祐愛会織田病院（佐賀県）、神戸大学医学部附属病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 04 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	Main results already published
Date of protocol fixation	2014 Year 08 Month 01 Day
Date of IRB	2014 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 08 Month 03 Day
Last modified on	2021 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016219