UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044239 |
|---|---|
| Receipt number | 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 | 2025/08/15 15:01:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
wakeyama@icloud.com
Sponsor or person
Institute
Japan Community Healthcare Organization Tokuyama Central Hospital
Institute
Department
Personal name
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
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
Completed
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
| 2025 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050521
