UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of Restenotic Neointimal Tissue after Second- or Third-Generation Drug-Eluting Stent Implantation: Evaluation by Histopathology, Optimal Coherence Tomography, and Intravascular Ultrasound
Title of the study (Brief title)	Assessment of Restenotic Neointimal Tissue after Second- or Third-Generation Drug-Eluting Stent Implantation: Evaluation by Histopathology, Optimal Coherence Tomography, and Intravascular Ultrasound
Region	Japan

Condition
Condition	Coronary Artery Disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess restenotic neointimal tissue after second- or third-generation drug-eluting stent implantation by using optical coherence tomography (OCT), intravascular ultrasound (IVUS), and histopathology analysis of tissue obtained by directional coronary atherectomy (DCA)
Basic objectives2	Others
Basic objectives -Others	Evaluation of pathological mechanism
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Histopathological findings, optical coherence tomography (OCT) findings, and intravascular ultrasound(IVUS) findings of restenotic neointimal tissue
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	-Patients who had restenosis after second- or third-generation DES implantation -Restenotic lesion considered appropriate to be treated by DCA -Patients considered appropriate to be used OCT for assessment of restenotic neointimal lesion from the patients background -Patients who have provided written informed consent
Key exclusion criteria	Those who were eligible to above criteria can be registered.
Target sample size	15

Research contact person
Name of lead principal investigator	Yuji Oikawa
Organization	The Cardiovascular Institute
Division name	Cardiology
Address	3-2-19, Nishiazabu Minato-ku, Tokyo, 106-0031, Japan
TEL	03-3408-2151
Email	y-oikawa@cvi.or.jp

Public contact
Name of contact person	Riku Arai
Organization	The Cardiovascular Institute
Division name	Cardiology
Address	3-2-19, Nishiazabu Minato-ku, Tokyo, 106-0031, Japan
TEL	03-3408-2151
Homepage URL
Email	r-arai@cvi.or.jp

Sponsor
Institute	The Cardiovascular Institute
Institute
Department

Funding Source
Organization	The Cardiovascular Institute
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	心臓血管研究所付属病院（東京都）　The Cardiovascular Institute 東海大学医学部内科学系循環器内科（神奈川県）　Department of cardiology, Tokai university hospital

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 04 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 08 Day
Anticipated trial start date	2018 Year 04 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Patients are recruiting

Management information
Registered date	2018 Year 04 Month 02 Day
Last modified on	2018 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036475