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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044239
Receipt No. R000050521
Scientific Title Assessment of early strut coverage after COMBO and Everolimus eluting stent using optical coherence tomography astudy
Date of disclosure of the study information 2021/05/18
Last modified on 2021/05/18

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Basic information
Public title Assessment of early strut coverage after COMBO and Everolimus eluting stent using optical coherence tomography astudy
Acronym Assessment of early strut coverage after COMBO and Everolimus eluting stent (COMMENT trial)
Scientific Title Assessment of early strut coverage after COMBO and Everolimus eluting stent using optical coherence tomography astudy
Scientific Title:Acronym Assessment of early strut coverage after COMBO and Everolimus eluting stent (COMMENT trial)
Region
Japan

Condition
Condition Ischemic Heart Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to compare the strut coverage between COMBO stent and everolimus eluting stent
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes strut coverage
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Patients were randomly assigned to receive either the COMBO stent or everolimus eluting stent.
Interventions/Control_2 One month later, we investigate the strut coverage using OCT.
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
20 years-old <=
Age-upper limit
95 years-old >=
Gender Male and Female
Key inclusion criteria Patients with two vessel disease who are planned to undergo percutaneous coronary intervention
Key exclusion criteria Patients with serum creatinine > 2.0mg/dl
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takatoshi
Middle name
Last name Wakeyama
Organization Japan Community Healthcare Organization Tokuyama Central Hospital
Division name Division of Cardiology
Zip code 745-8522
Address 1-1, Kodachou, Shunan, Yamaguchi, Japan
TEL +81-834-28-4411
Email wakeyama@icloud.com

Public contact
Name of contact person
1st name Takatoshi
Middle name
Last name Wakeyama
Organization Japan Community Healthcare Organization Tokuyama Central Hospital
Division name Division of Cardiology
Zip code 745-8522
Address 1-1, Kodachou, Shunan, Yamaguchi, Japan
TEL +81-834-28-4411
Homepage URL
Email wakeyama@icloud.com

Sponsor
Institute Japan Community Healthcare Organization Tokuyama Central Hospital
Institute
Department

Funding Source
Organization Japan Community Healthcare Organization Tokuyama Central 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 Tokuyama Central Hospital Ethics Committee
Address 1-1, Kodachou, Shunan, Yamaguchi, Japan
Tel +81-834-28-4411
Email miyazaki-naomi@tokuyama.jcho.go.jp

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
2021 Year 05 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2021 Year 03 Month 01 Day
Date of IRB
2021 Year 03 Month 03 Day
Anticipated trial start date
2021 Year 03 Month 26 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 18 Day
Last modified on
2021 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050521

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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