UMIN ID: UMIN000014749
Registered date:04/08/2014
A 3D-OCT investigation into coronary artery bifurcation lesion stent implantation technique
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Coronary artery bifurcation disease |
Date of first enrollment | 2014/08/01 |
Target sample size | 100 |
Countries of recruitment | Japan |
Study type | Interventional,observational |
Intervention(s) | To investigate coronaary bifurcation stenting with 2D, 3D OCT imaging. |
Outcome(s)
Primary Outcome | 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) |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude 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. |
Related Information
Primary Sponsor | 3D-OCT investigators |
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Secondary Sponsor | |
Source(s) of Monetary Support | 3D-OCT Investigators |
Secondary ID(s) |
Contact
public contact | |
Name | Junya Shite |
Address | 2-10-39, Shibata, Kita, Osaka Japan |
Telephone | 06-6372-0333 |
ricegoalflow@yahoo.co.jp | |
Affiliation | Osaka Saiseikai Nakatsu Hospital Cardiology |
scientific contact | |
Name | Junya Shite, Takayuki Okamura |
Address | 2-10-39, Shibata, Kita, Osaka Japan |
Telephone | 06-6372-0333 |
ricegoalflow@yahoo.co.jp | |
Affiliation | Osaka Saiseikai Nakatsu Hospital, Yamaguchi University Hospital Cardiology |