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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018860
Receipt No. 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 2018/03/04

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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
Email 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
Email kuramitsu@circulation.jp

Sponsor
Institute Department of Cardiology, Kokura Memorial Hospital
Institute
Department

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
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 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 Main results already published
Date of protocol fixation
2015 Year 03 Month 19 Day
Date of IRB
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
2018 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021634

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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