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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013515
Receipt No. 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

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Basic information
Public title Detect the Event of very late Stent failure from the drug-eluting stent NOT well covered by nEointima determined by angioscopy study
Acronym DESNOTE study
Scientific Title Detect the Event of very late Stent failure from the drug-eluting stent NOT well covered by nEointima determined by angioscopy study
Scientific Title:Acronym DESNOTE study
Region
Japan

Condition
Condition coronary heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Others
Basic objectives -Others Risk evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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.
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria NO
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasunori Ueda
Organization Osaka Police Hospital
Division name Cardiovascular Division
Zip code
Address 10-31 Kitayama-cho, Tennoji-ku, Osaka
TEL 06-6771-6051
Email yellowplaque@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori Ueda
Organization Osaka Police Hospital
Division name Cardiovascular Division
Zip code
Address 10-31 Kitayama-cho, Tennoji-ku, Osaka
TEL 06-6771-6051
Homepage URL
Email yellowplaque@gmail.com

Sponsor
Institute Cardiovascular Division, Osaka Police Hospital
Institute
Department

Funding Source
Organization none
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

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S1936879815002587
Number of participants that the trial has enrolled
Results 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.
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 Completed
Date of protocol fixation
2004 Year 12 Month 01 Day
Date of IRB
2004 Year 12 Month 01 Day
Anticipated trial start date
2004 Year 12 Month 21 Day
Last follow-up date
2013 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 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.

Management information
Registered date
2014 Year 03 Month 26 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015791

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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