UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018860 |
|---|---|
| Receipt number | R000021634 |
| Scientific Title | Long-Term Vascular Response to Everolimus-Eluting Stent: Five-year Follow-up Optical Coherence Tomography Study |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2023/07/04 18:48:27 |
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Basic information
Public title
Long-Term Vascular Response to Everolimus-Eluting Stent: Five-year Follow-up Optical Coherence Tomography Study
Acronym
Long-Term Vascular Response to Everolimus-Eluting Stent: Five-year Follow-up Optical Coherence Tomography Study
Scientific Title
Long-Term Vascular Response to Everolimus-Eluting Stent: Five-year Follow-up Optical Coherence Tomography Study
Scientific Title:Acronym
Long-Term Vascular Response to Everolimus-Eluting Stent: Five-year Follow-up Optical Coherence Tomography Study
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the long-term vascular response to everolimus-eluting stent
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantitative parameters and qualitative characteristics of the neointima
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
Patients had no cardiac adverse events in lesions treated with everolimus-eluting stents within 5-year after stent implantation.
Key exclusion criteria
1) Patients presented with acute coronary syndrome
2) index target lesions with coronary artery bypass graft
3) index target lesions with in-stent restenosis
4) left ventricular ejection fraction <30%
5) eGFR <30 ml/min/1.73m2
6) inability to give informed consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Ando |
Organization
Kokura Memorial Hospital
Division name
Cardiology
Zip code
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Japan
TEL
0935112000
kenji-ando@live.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoichi Kuramitsu |
Organization
Kokura Memorial Hospital
Division name
Cardiology
Zip code
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Japan
TEL
0935112000
Homepage URL
kuramitsu@circulation.jp
Sponsor or person
Institute
Department of Cardiology, Kokura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology, Kokura Memorial Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
小倉記念病院（福岡県）、産業医科大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2015 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) Study design: Cohort study
(2) Recruitment methods: From March 2015 to March 2016, we will enroll
the patients who fulfill the inclusion criteria and agree to participate in this study.
Management information
Registered date
| 2015 | Year | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021634
