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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014749
Receipt No. R000016219
Scientific Title A 3D-OCT investigation into coronary artery bifurcation lesion stent implantation technique
Date of disclosure of the study information 2014/08/04
Last modified on 2018/02/04

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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 No longer recruiting
Date of protocol fixation
2014 Year 08 Month 01 Day
Date of IRB
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
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 03 Day
Last modified on
2018 Year 02 Month 04 Day


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

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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