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
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
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
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
