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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026759
Receipt No. R000030721
Scientific Title Japanese prospective observational study of 3D-OCT guided bifurcation PCI
Date of disclosure of the study information 2017/04/01
Last modified on 2018/02/26

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Basic information
Public title Japanese prospective observational study of 3D-OCT guided bifurcation PCI
Acronym Japanese 3D-OCT Bifurcation Registry
Scientific Title Japanese prospective observational study of 3D-OCT guided bifurcation PCI
Scientific Title:Acronym Japanese 3D-OCT Bifurcation Registry
Region
Japan

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

Objectives
Narrative objectives1 Collect OCT images of percutaneous coronary intervention for coronary artery bifurcation lesions through multicenter registry study to evaluate the connection between the initial result of OCT guidance PCI and outcome and to validate its clinical benefit.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bifurcation area restenosis within a year after PCI in the Optimal group with side branch dilatation, Suboptimal group and the group with no side branch dilatation. (50% or more stenosis progression from immediately after the clinical trial due to nature of coronary angiography)
Key secondary outcomes Rate of major adverse cardiovascular events within 3 years after PCI.
Cardiac death, non-cardiac death, myocardial infarction, stent thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR), and renal dysfunction.
<Exploratory parameter>
An exploratory study on bifurcation stenting using 3D OCT imaging guide
*Jailed strut pattern, success rate of optimal cell re-crossing, PCI procedure time, contrast usage, and fluoroscopy time.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 with a de novo lesion in which stent will be implanted
2) Patient who has a side branch with visually confirmed luminal diameter of 2 mm or more
3) Age 20 years or older
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 STEMI and CTO lesion
4) Patient who is considered PCI not applicable 5) Patient whom physician in charge of the study determined not applicable
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junya Shite
Organization Osaka Saiseikai Nakatsu Hospital
Division name Cardiology
Zip code
Address 2-10-39, Sibata, Kita-ku, Osaka
TEL 06-6372-0333
Email shite@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoji Nagoshi
Organization Osaka Saiseikai Nakatsu Hospital
Division name Cardiology
Zip code
Address 2-10-39, Sibata, Kita-ku, Osaka
TEL 06-6372-0333
Homepage URL
Email rnagoshi-circ@umin.ac.jp

Sponsor
Institute Society of 3D-OCT(office: Osaka Saiseikai Nakatsu Hospital)
Institute
Department

Funding Source
Organization Abbott Vascular Japan Co.,Ltd., BEG Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 03 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 Patients planned for drug-eluting stent implantation to the coronary artery bifurcation lesion.
After IRB approval of the centers, data center will issue ID/PW and physicians from each center responsible for the study will register cases from the online registry system.

Management information
Registered date
2017 Year 03 Month 29 Day
Last modified on
2018 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030721

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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