UMIN-CTR Clinical Trial

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
Email	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
Email	oyakawa@haku-ai.or.jp

Sponsor
Institute	Makiminato Central Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043945