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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008059
Receipt No. R000009445
Scientific Title Impact of Serial OCT findings After Nobori Stenting in Japanese Patients
Date of disclosure of the study information 2012/05/30
Last modified on 2019/05/21

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Basic information
Public title Impact of Serial OCT findings After Nobori Stenting in Japanese Patients
Acronym Impact of Serial OCT findings After Nobori Stenting
Scientific Title Impact of Serial OCT findings After Nobori Stenting in Japanese Patients
Scientific Title:Acronym Impact of Serial OCT findings After Nobori Stenting
Region
Japan

Condition
Condition angina pectoris
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To solve safety and validity after Nobori stent implantation.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To solve the percentage of neointimal coverage after Nobori stent implantation by using OCT
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

Not applicable
Gender Male and Female
Key inclusion criteria (1)Older than 20 years old.
(2)Indication of PCI.
(3)To agree to review and record all the clinical course in this research protocol.
(4)The patient who are eligible to receive dual antiplatelet therapy at least more than 6 month.
(5)Informed concent with the document signed by the patients.

The patient have to correspond to all the above items at the time of registration.
Key exclusion criteria 1.The patient who died during the research
2.The patient with Stent thrombosis during the research.
3.Previous history of pancytopenia, liver function, renal dysfunction, hypersensitive history of the drug.
4.Low ejection fraction (LVEF<=30%), an impaired liver function, and renal dysfunction (eGFR<=30)
5.The patient excluded from a safety of a thiazolidine derivative.

lesion exclusion criteria
1.left main artery
2.severe calcification
3.stent restenosis

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiro Shinke
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
Homepage URL
Email

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization terumo
Organization
Division
Category of Funding Organization Profit organization
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
2012 Year 05 Month 30 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
2012 Year 04 Month 01 Day
Date of IRB
2012 Year 04 Month 15 Day
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2015 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information .

Management information
Registered date
2012 Year 05 Month 30 Day
Last modified on
2019 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009445

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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