UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038563 |
|---|---|
| Receipt number | R000043945 |
| Scientific Title | Usefulness of 2mm coronary stent in percutaneous coronary intervention for Japanese patients with ischemic heart disease |
| Date of disclosure of the study information | 2019/11/12 |
| Last modified on | 2020/09/01 18:29:47 |
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Basic information
Public title
Usefulness of 2mm coronary stent in percutaneous coronary intervention for Japanese patients with ischemic heart disease
Acronym
Usefulness of 2mm coronary stent in percutaneous coronary intervention for Japanese patients with ischemic heart disease
Scientific Title
Usefulness of 2mm coronary stent in percutaneous coronary intervention for Japanese patients with ischemic heart disease
Scientific Title:Acronym
Usefulness of 2mm coronary stent in percutaneous coronary intervention for Japanese patients with ischemic heart disease
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety of percutaneous coronary intervention with a 2mm stent (Resolute Onyx) for Japanese patients with symptomatic ischemic heart disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of target vessel adverse events after 12 months (cardiac death, target vessel myocardial infarction, target vessel revascularization)
Key secondary outcomes
Death, myocardial infarction, revascularization, and major bleeding after 12 months
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patinent with ischemic heart disease
2) Percutaneous coronary intervention is required
3) Candidate for 2mm coronary stent therapy
4) Patients with ischemic symptom, or patients whom ischemia is functionally proven
5) Over 20 years old
6) Written consent has been obtained
Key exclusion criteria
1) Recurrent fatal ventricular arrhythmia
2) Anticoagulation therapy was required
3) Acute myocardial infarction within 72 hours
4) Planned PCI of any vessel within 30 days
5) Planned PCI of the target vessel(s) within 12 months
6) Blood disorder (such as hemophilia)
7) Bleeding tendency
8) Unsuitable for safe participation
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Oyakawa |
Organization
Makiminato Central Hospital
Division name
Division of Cardiovascular Medicine
Zip code
901-2131
Address
1199 Makiminato, Urasoe city, Okinawa, 901-2131, Japan
TEL
098-877-0575
oyakawa@haku-ai.or.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Oyakawa |
Organization
Makiminato Central Hospital
Division name
Division of Cardiovascular Medicine
Zip code
901-2131
Address
1199 Makiminato, Urasoe city, Okinawa, 901-2131, Japan
TEL
098-877-0575
Homepage URL
oyakawa@haku-ai.or.jp
Sponsor or person
Institute
Makiminato Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Makiminato Central Hospital
Address
1199 Makiminato, Urasoe city, Okinawa, 901-2131, Japan
Tel
098-877-0575
motonaga@haku-ai.or.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
| 2019 | Year | 11 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2019 | Year | 11 | Month | 12 | Day |
Last modified on
| 2020 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043945
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
