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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033406
Receipt No. 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 2019/01/15

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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
Institute Nagano Municipal 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
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 Open public recruiting
Date of protocol fixation
2018 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
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
2019 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.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


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