UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033406
Receipt number R000038084
Scientific Title Early VAscular Response of siloLimus-elUting stent; Orsiro Assessed by OpTIcal frequency dOmaiN imaging
Date of disclosure of the study information 2018/08/01
Last modified on 2021/01/16 16:01:37

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Basic information

Public title

Early VAscular Response of siloLimus-elUting stent; Orsiro Assessed by OpTIcal frequency dOmaiN imaging

Acronym

EVALUATION

Scientific Title

Early VAscular Response of siloLimus-elUting stent; Orsiro Assessed by OpTIcal frequency dOmaiN imaging

Scientific Title:Acronym

EVALUATION

Region

Japan


Condition

Condition

Coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the early vascular response of siloLimus-elUting stent Orsiro by optical frequency domain imaging

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The rate of covered strut 4 weeks after stent implantation

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

The patients with 2 vessel coronary artery disease

Key exclusion criteria

1 The patients with LMT lesion
2 The patients with RCA ostial lesion
3 The patients with small lesion less than 2.0mm or large lesion more than 4.5mm
4 The CKD patients with Cre more than 2.0 mg/dl

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Miura

Organization

Nagano Municipal Hospital

Division name

Department of Cardiology

Zip code


Address

1333-1 Tomitake Nagano

TEL

026-295-1199

Email

miuramen10miuramen@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Miura

Organization

Nagano Municipal Hospital

Division name

Department of Cardiology

Zip code


Address

1333-1 Tomitake Nagano

TEL

026-295-1199

Homepage URL


Email

miuramen10miuramen@yahoo.co.jp


Sponsor or person

Institute

Nagano Municipal Hospital

Institute

Department

Personal name



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


Address


Tel


Email



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

2018 Year 08 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

Completed

Date of protocol fixation

2018 Year 05 Month 30 Day

Date of IRB

2018 Year 05 Month 30 Day

Anticipated trial start date

2018 Year 08 Month 01 Day

Last follow-up date

2020 Year 04 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2018 Year 07 Month 16 Day

Last modified on

2021 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038084


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name