UMIN-CTR Clinical Trial

Basic information
Public title	Vascular responses to COMBO stent for acute coronary syndrome by Optical Coherence Tomography Assessment
Acronym	Vascular responses to COMBO stent for acute coronary syndrome by Optical Coherence Tomography Assessment
Scientific Title	Vascular responses to COMBO stent for acute coronary syndrome by Optical Coherence Tomography Assessment
Scientific Title:Acronym	Vascular responses to COMBO stent for acute coronary syndrome by Optical Coherence Tomography Assessment
Region	Japan

Condition
Condition	The patients with acute coronary syndrome
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to elucidate the early phase vascular responses in patients with acute coronary syndrome (ACS) after COMBO stent implantation at 1 month follow-up by using optical coherence tomography (OCT).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint was that the degree of strut coverage which was evaluated by OCT at 1 month. Percentage of strut coverage was analyzed every 1 mm by OCT.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	All patients underwent percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) by using Combo stent.All patients were evaluated by Optical Coherence Tomography (OCT) immediately after stent implantation and were performed OCT follow-up after 1 month.
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	95 years-old >=
Gender	Male and Female
Key inclusion criteria	1) The patients with ACS need for PCI. 2) Target lesions are thought native coronary arteries. 3) The patients are possible to take antiplatelet drugs. 4) The patients or legal representative people agree this study and write informed consents after they understand this study protocol.
Key exclusion criteria	1) The patients with low ejection fraction (less than 20%). 2) The patients with recurrent myocardial infarction within 30 days. 3) The patients with fresh bleeding. 4) The patients with cerebral infarction within 6 months. 5) The patients with hemoglobin < 8.0 g/dl. 6) The patients with WBC <3000 or PLT < 100000. 7) The patients with positive HBV or HCV or HIV. 8) The patients with participate other clinical trial. 9, 10) The patients with pregnant women (including possible) or lactating women 11) The patients with renal failure (Cre>2.5 mg/dl) 12) The patients that research director judged inappropriate patients in this study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shigeru Middle name Last name Saito
Organization	ShonanKamakura General Hospital
Division name	Cardiology
Zip code	247-8533
Address	1370-1, Okamoto, Kamakura City
TEL	0467-46-1717
Email	transradial@kamakuraheart.org

Public contact
Name of contact person	1st name Koki Middle name Last name Shishido
Organization	ShonanKamakura General Hospital
Division name	Cardiology
Zip code	247-8533
Address	1370-1, Okamoto, Kamakura City
TEL	0467-46-1717
Homepage URL
Email	koki10192002@yahoo.co.jp

Sponsor
Institute	ShonanKamakura general Hospital, Cardiology
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Tokushukai Group Ethics Committee
Address	1-8-7 Kojimachi, Chiyoda-ku, Tokyo, Japan
Tel	03-3263-4801
Email	mirai-ec1@mirai-iryo.com

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	2020 Year 03 Month 24 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	2020 Year 03 Month 10 Day
Date of IRB	2020 Year 03 Month 10 Day
Anticipated trial start date	2020 Year 03 Month 12 Day
Last follow-up date	2021 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 24 Day
Last modified on	2020 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045508