UMIN-CTR Clinical Trial

Basic information
Public title	Early vascular healing of ultra-thin strut polymer-free sirolimus eluting stent in acute coronary syndrome: optical coherence tomography study
Acronym	USUI-ACS STUDY
Scientific Title	Early vascular healing of ultra-thin strut polymer-free sirolimus eluting stent in acute coronary syndrome: optical coherence tomography study
Scientific Title:Acronym	USUI-ACS STUDY
Region	Japan

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

Objectives
Narrative objectives1	To evaluate early vascular healing of ultra-thin strut polymer-free sirolimus eluting stent for the treatment of acute coronary syndrome using optical coherence tomography
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The percentage of covered struts at 3-month
Key secondary outcomes	The percentage of malapposed struts, mean neointimal hyperplasia (NIH) thickness, NIH area, thrombus and dissection

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	Patients who undergo OCT guided PCI for the treatment of acute coronary syndrome and ultra-thin strut polymer-free sirolimus eluting stent is implanted Patients who are able to undergo OCT examinations of the site of stent placement at 3 months Patients who are 20 years old and over at the time of informed consent Patients who have provided informed consent written by themselves
Key exclusion criteria	Female patient during pregnancy The culprit lesion is the left main coronary trunk or coronary bypass graft patients who are stable coronary artery diseases The culprit lesion is the in-stent restenosis chronic kidney disease as indicated by serum creatinine > 2.0 mg/dl
Target sample size	30

Research contact person
Name of lead principal investigator	1st name masami Middle name Last name nishino
Organization	osaka rosai hospital
Division name	cardiology
Zip code	591-8025
Address	3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
TEL	072-252-3561
Email	mnishino@osakah.johas.go.jp

Public contact
Name of contact person	1st name yutaka Middle name Last name matsuhiro
Organization	osaka rosai hospital
Division name	cardiology
Zip code	591-8025
Address	3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
TEL	072-252-3561
Homepage URL
Email	junnai-hisho@osakah.johas.go.jp

Sponsor
Institute	osaka rosai hospital
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	osaka rosai hospital
Address	3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
Tel	072-252-3561
Email	junnai-hisho@osakah.johas.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	2020 Year 11 Month 01 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 10 Month 23 Day
Date of IRB	2020 Year 10 Month 23 Day
Anticipated trial start date	2020 Year 10 Month 23 Day
Last follow-up date	2021 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We enroll the patients who undergo OCT guided PCI for the treatment of acute coronary syndrome and ultra-thin strut polymer-free sirolimus eluting stent is implanted. 3-month follow up OCT is performed and vascular healing including percentage of covered struts, malapposed struts and NIH thickness is evaluated and compared with those at post procedure.

Management information
Registered date	2020 Year 10 Month 28 Day
Last modified on	2020 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048256