Unique ID issued by UMIN | UMIN000013515 |
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Receipt number | R000015791 |
Scientific Title | Detect the Event of very late Stent failure from the drug-eluting stent NOT well covered by nEointima determined by angioscopy study |
Date of disclosure of the study information | 2014/04/01 |
Last modified on | 2019/04/08 15:57:21 |
Detect the Event of very late Stent failure from the drug-eluting stent NOT well covered by nEointima determined by angioscopy study
DESNOTE study
Detect the Event of very late Stent failure from the drug-eluting stent NOT well covered by nEointima determined by angioscopy study
DESNOTE study
Japan |
coronary heart disease
Cardiology |
Others
NO
To examine if angioscopic findings, especially the presence of yellow plaque, at one year after DES implantation would be a risk of future very late stent failure.
Others
Risk evaluation
Very late stent failure defined as 1) cardiac death, 2) myocardial infarction or unstable angina due to the target stent, or 3) target lesion revascularization. Cardiac death was defined as the death without known non-cardiac cause.
Observational
Not applicable |
Not applicable |
Male and Female
All patients who received successful angioscopic examination at planned one-year follow-up after the implantation of DES in the native coronary artery without any event of stent failure before the follow-up.
NO
300
1st name | |
Middle name | |
Last name | Yasunori Ueda |
Osaka Police Hospital
Cardiovascular Division
10-31 Kitayama-cho, Tennoji-ku, Osaka
06-6771-6051
yellowplaque@gmail.com
1st name | |
Middle name | |
Last name | Yasunori Ueda |
Osaka Police Hospital
Cardiovascular Division
10-31 Kitayama-cho, Tennoji-ku, Osaka
06-6771-6051
yellowplaque@gmail.com
Cardiovascular Division, Osaka Police Hospital
none
Other
NO
2014 | Year | 04 | Month | 01 | Day |
Partially published
http://www.sciencedirect.com/science/article/pii/S1936879815002587
In-stent atherosclerosis evaluated by yellow plaque at 1 year after the implantation of DES and the absence of statin therapy were risks of VLSF. The underlying mechanism of VLSF appeared to be the progression of atherosclerosis as demonstrated by the yellow plaque.
Completed
2004 | Year | 12 | Month | 01 | Day |
2004 | Year | 12 | Month | 01 | Day |
2004 | Year | 12 | Month | 21 | Day |
2013 | Year | 09 | Month | 30 | Day |
1) Yellow color, neointima coverage, and thrombus at the site of DES implantation will be examined by angioscopy. VLSF is defined as 1) cardiac death, 2) myocardial infarction or unstable angina due to the target stent, or 3) target lesion revascularization. Cardiac death is defined as the death without known non-cardiac cause.
2) The data on the patients background will be acquired from clinical record at the time of enrollment when angioscopic examination is performed.
3) Angioscopic observation of stented lesions is done while blood is cleared away from viewed by the injection of 3% dextran-40 as we have previously reported. Yellow color is classified into 4 grades (0: white, 1: slight yellow, 2: yellow, and 3: intensive yellow) comparing with standard colors as we have previously reported. Neointima coverage is classified into 3 grades (0: no coverage, 1: poor coverage, 2: complete coverage) as we have previously reported. Thrombus is defined as white or red material that had cotton-like or ragged appearance or that presented fragmentation with or without protrusion into lumen or adherent to the luminal surface. Maximum and minimum neointima coverage grade, maximum yellow color grade, and presence or absence of thrombus will be determined for each stented lesion. Presence of yellow plaque is defined as the maximum yellow color grade >=2.
4) Patients will be divided into 2 groups according to the presence or absence of yellow plaque at the site of stent implantation. Comparisons between the groups will be performed by unpaired student t-test or chi-square test. The incidence of VLSF will be compared between the groups using Kaplan-Meier methods and log rank test. To determine the risk factors for the occurrence of VLSF, multivariate Cox regression analysis will be performed.
2014 | Year | 03 | Month | 26 | Day |
2019 | Year | 04 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015791
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