UMIN-CTR Clinical Trial

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
Last 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
1st 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