UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041324
Receipt number R000047179
Scientific Title Early Vascular Response to Ultrathin Biodegradable-Polymer Sirolimus-Eluting Stents for The Treatment of ST-Elevation Myocardial Infarction After Plaque Rupture
Date of disclosure of the study information 2020/08/06
Last modified on 2020/08/06 18:25:24

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047179


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name