UMIN-CTR Clinical Trial

Basic information
Public title	Early Vascular Response to Ultrathin Biodegradable-Polymer Sirolimus-Eluting Stents for The Treatment of ST-Elevation Myocardial Infarction After Plaque Rupture
Acronym	BD-SES in STEMI
Scientific Title	Early Vascular Response to Ultrathin Biodegradable-Polymer Sirolimus-Eluting Stents for The Treatment of ST-Elevation Myocardial Infarction After Plaque Rupture
Scientific Title:Acronym	BD-SES in STEMI
Region	Japan

Condition
Condition	ST elevated myocardial infarction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess early Vascular Response to Ultrathin Biodegradable-Polymer Sirolimus-Eluting Stents for The Treatment of ST-Elevation Myocardial Infarction After Plaque Rupture
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of uncovered strut at 2 weeks after stent placemnent.
Key secondary outcomes

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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Consecutive patients with STEMI who underwent PCI.
Key exclusion criteria	cardiogenic shock, left main disease at the culprit lesion, reference vessel diameter less than 2.0 or 4.5 mm and more, chronic kidney disease defined as a serum creatinine 2.0 mg/dL and more, maintenance dialysis, life expectancy less than two years, planned surgery within three months, adverse reactions to aspirin or clopidogrel previously, warfarin intake before STEMI onset, age less than 20 years, pregnancy, and a previously treated culprit lesion in the stented segment. We further excluded patients who did not undergo OCT, did not show plaque rupture on OCT, and received DES other than BP-SES, patients who do not consent the study.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Shinke Middle name Last name Toshiro
Organization	Showa University School of Medicine
Division name	Division of Cardiology, Department of Medicine
Zip code	142-8666
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8664
Email	shinke@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Tsujita Middle name Last name Hiroaki
Organization	Showa University School of Medicine
Division name	Division of Cardiology, Department of Medicine
Zip code	142-8666
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8664
Homepage URL
Email	h.tsujita.19800517@hotmail.co.jp

Sponsor
Institute	Showa University School of Medicine, Division of Cardiology, Department of Medicine
Institute
Department

Funding Source
Organization	Showa University School of Medicine, Division of Cardiology, Department of Medicine
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 ethics committee of showa university graduate school of medicine
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel	03-3784-8000
Email	m-rinri@ofc.showa-u.ac.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	昭和大学病院

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 06 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	2018 Year 05 Month 01 Day
Date of IRB	2018 Year 05 Month 01 Day
Anticipated trial start date	2020 Year 08 Month 06 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To observe vascular response to ultrathin biodegradable-polymer sirolimus-eluting stents for the treatment of ST-elevation myocardial infarction.

Management information
Registered date	2020 Year 08 Month 05 Day
Last modified on	2020 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047179