Unique ID issued by UMIN | UMIN000026759 |
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Receipt number | 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 | 2021/08/12 14:06:06 |
Japanese prospective observational study of 3D-OCT guided bifurcation PCI
Japanese 3D-OCT Bifurcation Registry
Japanese prospective observational study of 3D-OCT guided bifurcation PCI
Japanese 3D-OCT Bifurcation Registry
Japan |
Coronary artery disease
Cardiology |
Others
NO
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.
Safety,Efficacy
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)
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.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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
600
1st name | Junya |
Middle name | |
Last name | Shite |
Osaka Saiseikai Nakatsu Hospital
Cardiology
5300012
2-10-39, Sibata, Kita-ku, Osaka
06-6372-0333
ricegoalflow@yahoo.co.jp
1st name | Ryoji |
Middle name | |
Last name | Nagoshi |
Osaka Saiseikai Nakatsu Hospital
Cardiology
5300012
2-10-39, Sibata, Kita-ku, Osaka
06-6372-0333
ryoji754@gmail.com
Society of 3D-OCT(office: Osaka Saiseikai Nakatsu Hospital)
Abbott Vascular Japan Co.,Ltd., BEG Co.,Ltd.
Profit organization
Osaka Saiseikai Nakatsu Hospital Institutional Review Board
2-10-39 Shibata, Kita-ku, Osaka
06-6372-0333
d_torii@nakatsu.saiseikai.or.jp
NO
2017 | Year | 04 | Month | 01 | Day |
Unpublished
Open public recruiting
2018 | Year | 01 | Month | 22 | Day |
2018 | Year | 03 | Month | 15 | Day |
2018 | Year | 03 | Month | 31 | Day |
2023 | Year | 03 | Month | 31 | Day |
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.
2017 | Year | 03 | Month | 29 | Day |
2021 | Year | 08 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030721
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