UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037277 |
|---|---|
| Receipt number | R000040186 |
| Scientific Title | Very long-term follow-up of drug-eluting stents assessed by coronary angioscopy (DESNOTE-Extend study) |
| Date of disclosure of the study information | 2019/07/05 |
| Last modified on | 2023/12/18 13:47:17 |
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Basic information
Public title
Very long-term follow-up of drug-eluting stents assessed by coronary angioscopy (DESNOTE-Extend study)
Acronym
DESNOTE-Extend study
Scientific Title
Very long-term follow-up of drug-eluting stents assessed by coronary angioscopy (DESNOTE-Extend study)
Scientific Title:Acronym
DESNOTE-Extend 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 were registered in the DESNOTE study.
Key exclusion criteria
No.
Target sample size
498
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Police Hospital
Division name
Cardiovascular Division
Zip code
543-0035
Address
10-31 Kitayama-cho, Tennoji-ku, Osaka
TEL
06-6771-6051
yhiguchi-ja@umin.net
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Sotomi |
Organization
Osaka Police Hospital
Division name
Cardiovascular Division
Zip code
543-0035
Address
10-31 Kitayama-cho, Tennoji-ku, Osaka
TEL
06-6771-6051
Homepage URL
sotomiyohei@gmail.com
Sponsor or person
Institute
Cardiovascular Division, Osaka Police Hospital
Institute
Department
Personal name
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
IRB, Osaka Police Hospital
Address
10-31 Kitayama-cho, Tennoji-ku, Osaka
Tel
06-6771-6051
yhiguchi-ja@umin.net
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
| 2019 | Year | 07 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2029 | Year | 04 | Month | 03 | 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
| 2019 | Year | 07 | Month | 05 | Day |
Last modified on
| 2023 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040186
